Stem cell treatment for acute myocardial infarction

Enca Martin‐Rendon; Susan Brunskill; Carolyn Doree; Chris Hyde; Anthony Mathur; Simon Stanworth; Suzanne Watt

doi:10.1002/14651858.CD006536.pub2

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Figure 1

QUOROM statement

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Analysis 1.1

Comparison 1 Stem cells compared to no stem cells, Outcome 1 Mortality.

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Analysis 1.2

Comparison 1 Stem cells compared to no stem cells, Outcome 2 Incidence of reinfarction.

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Analysis 1.3

Comparison 1 Stem cells compared to no stem cells, Outcome 3 Incidence of restenosis.

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Analysis 1.4

Comparison 1 Stem cells compared to no stem cells, Outcome 4 Incidence of hospital readmission.

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Analysis 1.5

Comparison 1 Stem cells compared to no stem cells, Outcome 5 Incidence of target vessel revascularisation.

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Analysis 1.6

Comparison 1 Stem cells compared to no stem cells, Outcome 6 LVESV mean change from baseline to end of study (>30 days ‐ 6 months).

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Analysis 1.7

Comparison 1 Stem cells compared to no stem cells, Outcome 7 LVESV comparison of mean end of study data (Echocardiography): 3 trials.

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Analysis 1.8

Comparison 1 Stem cells compared to no stem cells, Outcome 8 LVESV comparison of mean end of study data (Echocardiography): exploring heterogeneity ‐ baseline LVEF.

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Analysis 1.9

Comparison 1 Stem cells compared to no stem cells, Outcome 9 LVEDV mean change from baseline to end of study (>30 days to 6 months).

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Analysis 1.10

Comparison 1 Stem cells compared to no stem cells, Outcome 10 LVEDV comparison of mean end of study data (Echocardiography) : 4 trials.

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Analysis 1.11

Comparison 1 Stem cells compared to no stem cells, Outcome 11 LVEDV comparison of mean end of study data (Echocardiography): exploring heterogeneity ‐ timing of SCT.

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Analysis 1.12

Comparison 1 Stem cells compared to no stem cells, Outcome 12 Infarct size mean change from baseline to end of study (>30 days ‐ 6 months).

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Analysis 1.13

Comparison 1 Stem cells compared to no stem cells, Outcome 13 Infarct size mean change from baseline to end of study (MRI): exploring heterogeneity ‐ BMSC dose.

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Analysis 1.14

Comparison 1 Stem cells compared to no stem cells, Outcome 14 Infarct size mean change from baseline to end of study (MRI): exploring heterogeneity ‐ baselineLVEF.

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Analysis 1.15

Comparison 1 Stem cells compared to no stem cells, Outcome 15 Wall motion score mean change from baseline to end of study (>30 days ‐ 6 months).

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Analysis 1.16

Comparison 1 Stem cells compared to no stem cells, Outcome 16 Wall motion score mean change from baseline to end of study (Echocardiography): exploring heterogeneity ‐G‐CSF.

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Analysis 1.17

Comparison 1 Stem cells compared to no stem cells, Outcome 17 LVEF mean change from baseline to end of study (>30 days ‐6 months).

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Analysis 1.18

Comparison 1 Stem cells compared to no stem cells, Outcome 18 LVEF comparison of mean end of study data (Echocardiography): 4 trials..

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Analysis 1.19

Comparison 1 Stem cells compared to no stem cells, Outcome 19 LVEF mean change from baseline to end of study (MRI): exploring heterogeneity ‐ baseline pre SCT.

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Analysis 1.20

Comparison 1 Stem cells compared to no stem cells, Outcome 20 LVEF mean change from baseline to end of study ( MRI): exploring heterogeneity ‐ BMSC dose.

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Analysis 1.21

Comparison 1 Stem cells compared to no stem cells, Outcome 21 LVEF mean change from baseline to end of study (Angiography): exploring heterogeneity ‐ comparator.

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Analysis 1.22

Comparison 1 Stem cells compared to no stem cells, Outcome 22 LVEF mean change from baseline to emd of study (Angiography): exploring heterogeneity ‐ timing of SCT.

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Bone marrow stem cell (BMSC) treatment compared with no BMSC for people who has suffered acute myocardial infarction (AMI)
Patient or population: Anyone diagnosed with AMI Settings: Clinical diagnosis of AMI Intervention: BMSC infusion Comparison: No BMSC (control)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	no BMSC	BMSC
Mortality 1‐12 months	47 per 1000	30 per 1000 (6 to 200)	RR 0.62 (0.22 to 1.76)	391 (5 studies)	+++O moderate
Adverse Events (see comments)	See comments	See comments	Not estimable	296 (5 studies)	++OO low	The reporting of adverse events has been generally diverse. Details are not often given.The most apparent difference was found in two trials which included participants who received G‐CSF to mobilise BMSC into peripheral blood. These adverse events were associated to G‐CSF treatment. See Table 5.
LVEF (%) (MRI) 1‐6 months	See comments	See comments	WMD 2.19 % (‐1.15, 5.53)	298 (5 studies)	++OO low	LVEF measurements are given in percenta
Echo, echocardiography; G‐CSF, granulocyte colony stimulating factor; LV, left ventricular; LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; RR, relative risk; SPECT, single photon emission computed tomography; WMD, weighted mean difference. GRADE Working Group grades of evidence High quality (++++): Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality (+++O): Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality (++OO): Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality (+OOO): We are very uncertain about the estimate. For the 'Quality of the evidence' values, the highest weight was given to 'study limitations' and 'inconsistent results'. No studies were marked down for indirectness of evidence. Publication bias was not formally tested since there are very few studies (< 10 studies) in each major outcome to perfom a funnel plot and have meaningful results. Study limitations: it was considered 'serious' (‐1) when <50% of studies had adequate (YES) randomisation methods and blinding of outcome assessors and 'very serious' (‐2) when <75% of studies had adequate randomisation methods and blinding of outcome assessors. Inconsistent results: it was considered 'serious' (‐1) if a high degree of statistical heterogeneity was observed (I² > 50%).

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Table 1. Glossary

Term

Definition

AMI

BHF

BMSC

CABG

CMR

G‐CSF

INAHTA

ISI

ISTAHC

LAD

LVEDV

LVEF

LVESV

MNC

MRI

NBS

NHSBT

PCI

QoL

RCT

SEM

SPECT

WMD

Adverse events

Acute myocardial infarction

British Heart Foundation

Bone marrow

Bone marrow‐derived stem/progenitor cells

Coronaty artery bypass graft

Cardiac magnetic resonance

Granulocyte colony stimulating factor

High dose

International Netwrok of Agencies of Health and Technology Assessment

ISI

International Society of Technology Assessment in Health Care

Left anterior descending

Low dose

Left ventricle/left ventricular

Left ventricular end‐dyastolic volume

Left ventricular ejection fraction

Left ventricular end‐systolic volume

Myocardial infarction

Mononuclear cells

Magnetic resonance imaging

National Blood Service

National Health Service Blood and Transplant

Percutaneous coronary intervention

Quality of life

Randomised controlled trial

Relative risk

Standard deviation

Standard error of the mean

Single photon emission computed tomography

Weighted mean difference

Table 1. Glossary

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Table 2. Number of participants randomised and included in outcome analyses.

Trial	Trial Arm	Number randomised	No. clinical*	% missing	No. scientific*	% missing	Reasons exclusion	Overall no. lost	Reasons loss
Huang 2006	BMSC	20	20	0	20	0	N/a	0	N/a
	Control	20	20	0	20	0	N/a	0	N/a
Janssens 2006	BMSC	33	33	0	30	9%	Paired analysis for all scientific outcomes was available for 30 participants only.	3	1 participant died at 2 months, 1 suffered claustraphobia to MRI and 1 refused to undergo MRI.
	Control	34	34	0	30	12%	Paired analysis for all scientific outcomes was available for 30 participants only.	4	1 suffered claustraphobia to MRI and 1 refused to undergo MRI, 1 was unable to undergo MRI due to an intracochlear implant and 1 technical failure prevented MRI evalution.
Kang 2006	BMSC	27	25	7%	25	7%	2 participants were not avaiable for all outcome analyses, 1 participant moved to another hospital and 1 could not visit the outpatient clinic for follow‐up due to severe arthritis.	2	See previous column
	Control	29	25	7%	25	14%	4 participants were not avaiable for all outcome analyses: 1 participant died after 1 month and 3 participants moved to another hospital.	4	See previous column
Karpov 2005	BMSC	22	22	0	22	0	N/a	4	Not reported
	Control	22	22	0	22	0	N/a	3	Not reported
Li 2007	BMSC	35	35	0	35	0	N/a	0	N/a
	Control	35	23	34%	23	34%	12 participants were not available for follow‐up at 6 months: the trial does not report reasons for this non availability.	12	See previous column
Lunde 2006	BMSC	50	50, except for MRI measured outcomes: LVEF & LVEDV n = 44; infarct size, n = 43	0 (12%, 14%)	50	0	Paired analysis for all scientific outcomes measured by MRI were available for stated number of participants only.	0	N/a
	Control	51	50, except for MRI measured outcomes: LVEF n = 44; LVEDV & infarct size, n = 43	2% (14%, 16%)	50	2%	Paired analysis for all scientific outcomes measured by MRI were available for stated number of participants only.	1	1 participant suffered reinfarction and cardiac shock at day +11 and received a heart transplant day +30. Results for this participant not included in the review.
Meluzin LD 2006	BMSC	48 across the LD and HD treatment arms.	22	9%**	22	9%**	**4 participants were not included in outcome analysis: 1 participant had an inaequate number of BMSCs implanted and 3 participants suffered complication within 20 hours before BMSCs infused (2 x fever, 1 x bradycardia). Final outcome for these patisnts was not reported.	4**	See previous column
	Control	25	22	12%	22	12 %	3 participants were not included in outcome analysis: 2 underwent repeat MI two days following hospital discharge, due to in‐stent thrombosis and it was not possible to confirm findings in 1 participant. Final outcome for these patisnts was not reported.	3	See previous column
Meluzin HD 2006	BMSC	48 across the LD and HD treatment arms.	22	9%**	22	9 %**	**4 participants were not included in outcome analysis: 1 participant had an inaequate number of BMSCs implanted and 3 participants suffered complication within 20 hours before BMSCs infused (2 x fever, 1 x bradycardia). Final outcome for these patisnts was not reported.	4**	See previous column
	Control	25	22	12%	22	12%	3 participants were not included in outcome analysis: 2 underwent repeat MI two days following hospital discharge, due to in‐stent thrombosis and it was not possible to confirm findings in 1 participant.	3	See previous column
Ruan 2005	BMSC	9	N/a	N/a	9	0	N/a	0	N/a
	Control	11	N/a	N/a	11	0	N/a	0	N/a
Schachinger 2006	BMSC	101	101	0	95	6%	Paired LV angiograms were not available for 6 participants at 4 months follow‐up for scientific outcomes:: 1 = poor quality results on angiography, 2 died, 2 declined trial follow‐up, 1 did not undergo angiography at 4 months	6	See previous column
	Control	103	103	0	92	011%	Paired LV angiograms were not available for 9 participants at 4 months follow‐up for scientific outcomes: 1 = poor quality results on angiography, 2 died, 3 declined trial follow‐up, 3 did not undergo angiography at 4 months.	9	See previous column
Meyer 2006b	BMSC	33	30, except for outcome restenosis: n = 28	9% (15%)	30	9%	3 participants were withdrawn following randomisation because they were not able to undergo MRI due to claustrophobia or severe obesity.	0	N/a
	Control	32	30, except for outcome restenosis: n = 28	7% (13%)	30	7%	2 participants were withdrawn following randomisation because they were not able to undergo MRI due to claustrophobia or severe obesity.	0	N/a
Ge 2006	BMSC	10	10	N/a	10	0	N/a	0	N/a
	Control	10	10	N/a	10	0	N/a	0	N/a
Penicka 2007	BMSC	17	17	0	14	18%	Only 14/17 randomised provided functional outcome data at 4 months follow‐up. Three patients had died before the 4 month follow‐up	3	See previous column
	Control	10	10	0	10	0	N/a	0	N/a
Saurez de Lezo 2007	BMSC	10	10	0	10	0	N/a	0	N/a
	Control	10	10	0	10	0	N/a	0	N/a
BMSC, bone marrow‐derived stem cells; HD, high dose; LD, low dose; LV, left ventricular; LVEDV, left ventricular end‐diastolic volume; LVEF, left ventricular ejection fraction; MRI, magnetic resosnance imaging. * Indicates the number of participants included in the analyses of these groups of outcomes. This number may differe from the number lost to follow‐up overall. ** 4/44 (9%) participants were not included: trial does not separate this data by LD or HD treatment arm.

Table 2. Number of participants randomised and included in outcome analyses.

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Table 3. Summary of Included Trial Characteristics

Trial	Timepoint measured	Measurement	MI primary treatment	Co‐intervention	BMSC processing	Comparator Arm*	Timing of SC from MI	Dose BMSC**
Huang 2006	6 months	Angiography, MRI	PCI	None	+ gradient centrifugation	Control media: heparinised saline	Within 24‐48 hours of AMI	</= 1 x 10 (9)
Janssens 2006	4 months	MRI	PCI	None	+ gradient centrifugation	Placebo: Saline + 5% autologous serum	Within 24‐48 hours of AMI	</= 1 x 10 (9)
Kang 2006	6 months	MRI	PCI	G‐CSF to assist BMSC mobilisation	G‐CSF	Nothing	Patients randomised within 7 days of onset of AMI. Timing of SCT not specifically stated.	</= 1 x 10 (10)
Karpov 2005	6 months	Not applicable	PCI	None	+ gradient centrifugation	Comtrol	During coronaroangiography on day 7‐21 following AMI.	</= 1 x 10 (8)
Li 2007	6 months	Echocardiography	PCI	G‐CSF to assist BMSC mobilisation	G‐CSF	Not stated	BMSC infused on day 6 following AMI. Participants presented within a mean of 1 day following AMI.	</= 1 x 10 (8)
Lunde 2006	6 months	SPECT, Echocardiography, MRI	PCI	None	+ gradient centrifugation	Placebo: heparinised plasma	Median of 6 days following AMI.	</= 1 x 10 (8)
Meluzin (LD) 2006	3 months	SPECT	PCI	None	+ gradient centrifugation	Control media	Mean 7 days (SE 0.3) days following AMI	</= 1 x 10 (7)
Meluzin (HD) 2006	3 months	SPECT	PCI	None	+ gradient centrifugation	Control media	Mean 7 days (SE 0.3) days following AMI	</= 1 x 10 (8)
Ruan 2006	6 months	Echocardiography	PCI	None	Not stated	Control media	within approximately 15 hours of AMI. Mean time from onset to PCI was 12.1 hours and BMSCs infused within 2 hours of succesful PCI.	Not stated
Schachinger 2006	4 months; 12 months	Angiography	PCI	None	+ gradient centrifugation	Placebo: X‐vivo media + 20% autologous serum	Within 5 days of AMI. Reperfusion occured within 7.5 hours of symptom onset. Mean time from reperfusion to BMSC infusion was 4.4 days.	</= 1 x 10 (9)
Meyer 2006b	6 months; 18 months	MRI	PCI	None	+ gradient centrifugation	Control media: heparinised plasma	Mean time from AMI onset to BMSC harvest = 5.7 days. BMScs infused 6‐8 hours after BMSC harvest.	</= 1 x 10 (10)
Ge 2006	6 months	SPECT, Echocardiography	PCI	None	+ gradient centrifugation	Control: bone marrow supernatant	Within approximately 15 hours of AMI.	</= 1 x 10 (7)
Penicka 2007	4 months; 12 months	SPECT, Echocardiography	PCI	None	Not stated	Control: "Standard medical therapy"	Median time from AMI to PCI = more than 5 hours (range 5 to 11 hours). Median time from PCI to BMNC infusion = 9 days (range 4 to 11 days).	</= 1 x 10 (8)
Saurez de Lezo 2007	3 months	Angiography	PCI	None	+ gradient centrifugation	Control: sodium chloride with heparin	Approximately 10 to 12 days following AMI. PCI within 3‐5 days of AMI. BMSC infusion within a mean of 7 (SD 2) days of PCI.	</= 1 x 10 (9)
AMI, acute myocardial infarction; BMSC, bone marrow‐derived stem cells; G‐CSF, granulocyte colony stimulating factor; MRI, magnetic resonance imaging; PCI, percutaneous coronary intervention; SD, standard deviation; SPECT, single photon emission computed tomography. * as per the terminology used in the included trial. **Dose of BMSC administered were standardised and grouped by order of magnitude (ranging from 1x10⁷ to 2.46x10⁹ BMSC).

Table 3. Summary of Included Trial Characteristics

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Table 4. Clinical Outcomes ‐ Actual Data Table

Trial	Number randomised	Mortality	Morbid: reinfarction	Morbid: arrhythmias	Morbid: restenosis	Morbid: readmission	Mordid:revascular'n	Quality of Life	Re‐operation
Ge 2006	BMSC: 10; Control: 10	none reported	not reported	not reported	not reported	not reported	not reported	not reported	not reported
Huang 2006	BMSC: 20; Control: 20	none reported	not reported	not reported	not reported	not reported	not reported	not reported	not reported
Janssens 2004	BMSC: 33; Control: 34	BMSC: 1= haemorrhagic shock (2 months); Control: 0	not reported	BMSC: 5 x supra ventricular arrhythmias; Control: 9 arrhythmias (6 x supra ventricular, 3 x ventricular). (Timepoints not reported).	BMSC: 0; Control : 1 (12 months).	not reported	not reported	not reported	not reported
Kang 2006	BMSC: 25; Control: 25	BMSC: 0; Control: 1 = reinfarction (1 month).	BMSC: 0; Control: 1 (4 months): patient died.	not reported	BMSC: 0; Control : 2 (6 months).	not reported	BMSC: 0; Control: 1 (6 months)	not reported	not reported
Karpov 2005	BMSC: 22; Control: 22	none reported	Incidences reported in both trial arms. The exact number of incidences and outcome for the patient were not reported.	not reported	Incidences reported in both trial arms. The exact number of incidences and outcome for the patient were not reported.	not reported	not reported	See Additional Table 07	not reported
Li 2007	BMSC: 35; Control: 35	none reported	not reported	not reported	not reported	not reported	not reported	not reported	not reported
Lunde 2006	BMSC: 50; Control: 51	none reported	not reported	not reported	BMSC: 11; Control: 11 (up to and at 6 months follow‐up).	BMSC: 5; Control: 7 (both 6 months)	not reported	not reported	not reported
Meluzin LD 2006	BMSC: 22; Control: 22	none reported	BMSC: 0; Control: 2 (4 months).	not reported	BMSC: 4; Control: 1 ( both 6 months).	not reported	BMSC: 1*; Control: 0 (3 months)	not reported	not reported
Meluzin HD 2006	BMSC: 22; Control: 22	none reported	BMSC: 1; Control: 2 (4 months).	not reported	BMSC: 2; Control: 1 ( both 6 months).	not reported	BMSC: 1*; Control: 0 (3 months)	not reported	not reported
Ruan 2005	BMSC: 9; Control: 11	none reported	not reported	not reported	not reported	not reported	not reported	not reported	not reported
Schachinger 2006	BMSC: 101; Control: 103	BMSC: 2 = 1 x myocardial rupture, 1 x sudden death (4 months). Control: 6 = 1 x myocardial rupture, 1 x reinfarction, 1 x sudden death, 1 x heart failure, 1 x stroke, 1 x cancer. 2 deaths reported at 4 months, 4 death at 12 months. Cause of death was not reported per follow‐up timepoint.	BMSC: 0; Control: 6 (12 months).	not reported	not reported	BMSC: 0; Control : 3 (12 months).	BMSC: 16; Control: 26 (both 12 months)	not reported	BMSC: 22; Control: 37 (both 12 months)
Meyer 2006b	BMSC: 30; Control: 30	BMSC: 0; Control: 1 = progressive heart failure (9 months).	BMSC: 1 (4 months): patient underwent successful PCI and went on to complete the trial.; Control: 0	not reported	BMSC: 10; Control: 9 ( both 6 months).	BMSC: 1; Control: 3 (both 6 months)	BMSC: 5; Control: 4 (both 18 months)	not reported	not reported
Penicka 2007	BMSC: 17; Control: 10	BMSC: 3 = 1 x severe heart failure; 1 x spesis & ARDS; 1 x bilary carcinoma. Only the patient who died of bilary carcinoma had received BMSC infusion; Control = 1	BMSC: 2: 1 (BMSC harvest). Patient received repeat PCI and CABG but died 2 weeks later from sepsis; 1 (9 months) due to LAD occlusion distally; Control: 0.	none reported	not reported	BMSC: 1; Control: 1 (timepoint not stated, both due to worsening heart failure).	BMSC: 24%; Control: 40% (both by 4 months)	not reported	not reported
Saurez de Lezo 2007	BMSC: 10; Control: 10	none reported	not reported	not reported	not reported	not reported	not reported	not reported	not reported
BMSC, bone marrow‐derived stem cells; CABG, coronary artery bypass graft; LAD, left anterior descending; PCI, percutaneous coronary intervention. Text identifies the follow‐up timepoint at which the incidences were reported. * The Meluzin paper does not specify which BMSC treatment (low or high dose) the patient requiring target vessel revascularisation received.

Table 4. Clinical Outcomes ‐ Actual Data Table

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Table 5. Adverse Events

Trial	Trial Arm	Number AE's	Adverse event	G‐CSF related?	Outcome
Kang 2006	BMSC	6 participants reported experiencing an AE.	Bone pain (2), headache (2), injection site tenderness (1), dizziness (1).	Trial reported that all adverse events were transient and G‐CSF related	Transient, all resolved on stopping treatment.
	Control	0
Li 2007	BMSC	25 events. Number of participants experiencing an AE was not reported.	AE's during mobilization: bone pain (6); fever (3); skin rashes (1); weakness (2); spleen thrombosis (1). AEs during separating and collecting: low calcium effects (3), angina (2). AE's during BMSC transplantation: bradycardia (1), sinus arrest (1), ventricular fibrillation (1), hypotension (4).	Not specifically stated, but could be assumed that the bone pain, fever and skin trashes experienced during mobilization were G‐CSF related.	All resolved on stopping procedures. No severe complications or death reported following AEs.
	Control	0
Lunde 2006	BMSC	4	Stent thrombosis (2), contamination of stem cells with coagulase negative staphlycocus (1), ventricular fibrilation day 6 = 24 hours post BMSC infusion (1)	N/a	Stent thrombosis: PCI performed instead of BMSC infusion. Contamination and ventricular fibrilation resolved with no long term effects.
	Control	1	Pulseless ventricular tachycardia (1)		Converted to sinus rhythm by means of a precordial thump on day 2.
Meluzin (LD) 2006	BMSC	2 participants	Small thrombus (1), fever after transplant (1). AEs not reported by treatment dose.	N/a	Both AEs resolved with no long term complications.
	Control	0
Meluzin (HD) 2006	BMSC	2 participants	See Meluzin (LD) 2006.	N/a	See Meluzin (LD) 2006.
	Control	0
AE, adeverse events; BMSC, bone marrow‐derived stem cells; G‐CSF, granulocyte colony stimulating factor; PCI, percutaneous coronary intervention.

Table 5. Adverse Events

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Table 6. Quality of Life measures: results for Karpov 2005

QoL measure	BMSC (22)	Control (22)
6 min walking test (m): AMI day +21	429.60 (116.00) m	432.90 (124.50) m
6 min walking test (m): AMI month +3	498.50 (90.00) m	475.00 (148.50) m
6 min walking test (m): AMI month +6	563.00 (143.00) m	493.00 (118.00) m

QoL score : AMI day +21	18.50 (20.00)	19.00 (8.30)
QoL score : AMI month +3	26.50 (16.20)	29.30 (16.90)
QoL score : AMI month +6	33.10 (21.90)	26.00 (14.10)
Scores presented as mean (SD). AMI, acute myocardial infarction; BMSC, bone marrow‐derived stem cells; QoL, quality of life; SD, standard deviation.

Table 6. Quality of Life measures: results for Karpov 2005

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Table 7. Scientific Outcomes: Actual Data Table

Trial	Trial Arm	Timing Measurement	LVEF	LVESV	LVEDV	Myocardial lesion	Wall motion score
Huang 2006	BMSC	Baseline: mean (SD) ‐ at 1 week	Angiography: 56.7 (7.3) %; MRI (at 1 week): 44.5 (7.1) %	not measured	MRI: 130 (5) ml	MRI: (at 1 week): 21.0 (4.5) %	not measured
		End: mean (SD) ‐ at 6 months	Angiography: 60.0 (6) %; MRI: 51.5 (5.2) %		MRI: 117 (5) ml	MRI: 12.3 (2.6) %
		Mean (SD) change	Angiography: 3.3 (2.92) %; MRI: 7.0 (6.20) %		MRI: ‐13 (11.51) ml	MRI: ‐8.7 (7.71) %
	Control	Baseline: mean (SD) ‐ at 1 week	Angiography: 57.3 (8.2) %; MRI (at 1 week): 43.4 (6.7) %	not measured	MRI: 130 (6) ml	MRI: 22.3 (4.6) %	not measured
		End: mean (SD) ‐ at 6 months	Angiography: 58.5 (6.5) %; MRI: 47.9 (6.7) %		MRI: 120 (6) ml	MRI: 19.1 (4.5) %
		Mean (SD) change from baseline	Angiography: 1.2 (2.16) %; MRI: 4.5 (3.99) %		MRI: ‐10 (8.86) ml	MRI: ‐3.2 (2.83) %
Janssens 2006	BMSC	Baseline: mean (SD)	MRI: 48.5 (7.2) %	MRI: 42.2 (10.5) ml/m2	MRI: 81.2 (14) ml/m2	MRI: 20.6 (14.3) g	not measured
		End: mean (SD) ‐ at 4 months	MRI: 51.8 (8.8) %	MRI: 41.0 (15.5) ml/m2	MRI: 84.1 (20.8) ml/m2	MRI: 10.3 (8.0) g
		Mean (SD) change from baseline	MRI: 3.4 (6.9) %	MRI: ‐1.1 (11.2) ml/m2	MRI: 2.8 (15.2) ml/m2	MRI: ‐10.2 (7.9) g
	Control	Baseline: mean (SD)	MRI: 46.9 (8.2) %	MRI: 44.4 (12.3) ml/m2	MRI: 83.1 (14.2) ml/m2	MRI: 22.3 (16.1) g	not measured
		End: mean (SD) ‐ at 4 months	MRI: 49.1 (10.7) %	MRI: 45.0 (17.9) ml/m2	MRI: 85.9 (19.5) ml/m2	MRI: 14.7 (9.3) g
		Mean (SD) change from baseline	MRI: 2.2 (7.3) %	+MRI: 0.6 (11.6) ml/m2	MRI: 2.8 (15.0) ml/m2	MRI: ‐7.9 (8.5) g
Kang 2006	BMSC	Baseline: mean (SD)	MRI: 52.0 (9.9) %	MRI: 69.0 (21.5) ml	MRI: 143.1 (27.2) ml	not measured	not measured
		End: mean (SD) ‐ at 6 months	MRI: 57.1 (8.7) %	MRI: 63.5 (20.3) ml	MRI: 146.5 (27.6) ml
		Mean (SD) change from baseline	MRI: 5.1 (9.1) %	MRI: ‐5.4 (17.0) ml	MRI: 3.4 (14.48) ml
	Control	Baseline: mean (SD)	MRI: 53.2 (13.3) %	MRI: 62.7 (30.9) ml	MRI: 129.8 (28) ml	not measured	not measured
		End: mean (SD) ‐ at 6 months	MRI: 53.1 (11.5) %	MRI: 69.2 (38) ml	MRI: 139.9 (42.7) ml
		Mean (SD) change from baseline	MRI: ‐0.2 (8.6) %	MRI: 6.5 (21.9) ml	MRI: 10.1 (21.93) ml
Karpov 2005	BMSC	Baseline: mean (SD)	not measured	not measured	not measured	not measured	not measured
		End: mean (SD)
		Mean (SD) change from baseline
	Control	Baseline: mean (SD)	not measured	not measured	not measured	not measured	not measured
		End: mean (SD)
		Mean (SD) change from baseline
Li 2007	BMSC	Baseline: mean (SD)	Echocardiography: 50.0 (8.2) %	Echocardiography: 63.8 (24.9) ml	Echocardiography: 134.2 (36.7) ml	not measured	Echocardiography: 1.219 (0.190)
		End: mean (SD) ‐ at 6 months	Echocardiography: 57.1 (7.8) %	Echocardiography: 52.6 (20.3) ml	Echocardiography: 119.2 (30.3) ml		Echocardiography: 1.101 (0.118)
		Mean (SD) change from baseline	Echocardiography: 7.1 (6.30) %	Echocardiography: ‐11.2 (15.61) ml	Echocardiography: ‐15 (30.21) ml		Echocardiography: ‐0.118 (0.10)
	Control	Baseline: mean (SD)	Echocardiography: 51.0 (8.1) %	Echocardiography: 59.4 (25.3) ml	Echocardiography: 122.1 (35.3) ml	not measured	Echocardiography: 1.243 (0.177)
		End: mean (SD) ‐ at 6 months	Echocardiography: 52.6 (5.7) %	Echocardiography: 52.6 (9.6) ml	Echocardiography: 113.5 (24.1) ml		Echocardiography: 1.184 (0.138)
		Mean (SD) change from baseline	Echocardiography: 1.6 (8.64) %	Echocardiography: ‐6.8 (29.47) ml	Echocardiography: ‐8.6 (20.15) ml		Echocardiography: ‐0..059 (0.19)
Lunde 2006	BMSC	Baseline: mean (SD) ‐ at 2‐3 weeks following SCT	SPECT: 41.3 (10.4) %; Echocardiography: 45.7 (9.4) %; MRI (at 2‐3 weeks) 54.8 (13.6) %	not measured	SPECT: 162.3 (59.1) ml; Echocardiography: 136.1(30.5) ml; MRI (at 2‐3 weeks) 161.7 (46.3) ml	SPECT: 43.8 (17.4) %; MRI: 41.4 (27.6) ml	not measured
		End: mean (SD) ‐ at 6 months	SPECT: 49.3 (13.2) %; Echocardiography: 48.8 (10.7)%; MRI 56.2 (14.9) %		SPECT: 151.1(52.9) ml; Echocardiography: 145.0 (42.0) ml; MRI 154.1 (54.1) ml	SPECT: 32.8 (20.4) %; MRI: 38.7 (26.9) ml
		Mean (SD) change from baseline	SPECT: 8.1 (11.2) %; Echocardiography: 3.1 (7.9) %; MRI: 1.2 (7.5) %		SPECT: ‐11.2 (36.0) ml; Echocardiography: 8.9 (28.5) ml; MRI ‐6.9 (34.3) ml	SPECT: ‐11.0 (12.7) %; MRI: ‐2.3 (11.2) ml
	Control	Baseline: mean (SD) ‐ at 2‐3 weeks following SCT	SPECT: 42.6 (11.7) %; Echocardiography: 46.9 (9.6) %; MRI (at 2‐3 weeks) 53.6 (11.6) %	not measured	SPECT: 148.0 (46.3) ml; Echocardiography: 132.0 (34.6) ml; MRI (at 2‐3 weeks) 165.3 (46.7) ml	SPECT: 38.3 (21.1) %; MRI: 39.0 (29.5) ml	not measured
		End: mean (SD) ‐ at 6 months	SPECT: 49.3 (11.0) %; Echocardiography: 49.0 (9.5)%; MRI 58.1 (11.4) %		SPECT: 146.0 (50.0) ml; Echocardiography: 142.7 (45.2) ml; MRI 162.5 (45.3) ml	SPECT: 30.5 (20.9) %; MRI: 33.6 (23.7) ml
		Mean (SD) change from baseline	SPECT: 7.0 (9.6) %; Echocardiography: 2.1 (9.2) %; MRI: 4.3 (7.1) %		SPECT: ‐1.8 (17.6) ml; Echocardiography: 10.8 (29.1) ml; MRI ‐2.8 (20.0) ml	SPECT: ‐7.8 (8.7) %; MRI: ‐5.9 (13.6) ml
Melzuin (LD) 2006	BMSC	Baseline: mean (SD)	SPECT: 42 (SEM 2) %	SPECT: 92 (SEM 8) ml	SPECT: 154 (SEM 10) ml	SPECT: 43 (SEM 3) %	Echocardiography:4.5 (SEM 0.3) cm/s
		End: mean (SD) ‐ at 3 months	SPECT: 45 (SEM 2) %	SPECT: 89 (SEM 8) ml	SPECT: 158 (SEM 10) ml	SPECT: 35 (SEM 4) %	Echocardiography: 5.0 (SEM 0.3) cm/s
		Mean (SD) change from baseline	SPECT: 3 (SD 4.69) %	SPECT: ‐3 (SD 23.45) ml	SPECT: 4 (SD 32.8) ml	SPECT: ‐8 (SD 9.38) %	Echocardiography: ‐0.5 (SD 0.938) cm/s
	Control	Baseline: mean (SD)	SPECT: 42 (SEM 2) %	SPECT: 93 (SEM 8) ml	SPECT: 156 (SEM 9) ml	SPECT: 41 (SEM 4) %	Echocardiography: 5.2 (SEM 0.3) cm/s
		End: mean (SD) ‐ at 3 months	SPECT: 44 (SEM 2) %	SPECT: 100 (SEM 10) ml	SPECT: 172 (SEM 12) ml	SPECT: 33 (SEM 4) %	Echocardiography:5.2 (SEM 0.3) cm/s
		Mean (SD) change from baseline	SPECT: 2 (SD 4.69) %	SPECT: 7 (SD 28.14) ml	SPECT: 16 (SD 32.8) ml	SPECT: ‐8 (SD 14.07) %	Echocardiography: 0.0 (SD 0.469) cm/s
Melzuin (HD) 2006	BMSC	Baseline: mean (SD)	SPECT: 41 (SEM 2) %	SPECT: 98 (SEM 10) ml	SPECT: 158 (SEM 13) ml	SPECT: 43 (SEM 4) %	Echocardiography: 4.3 (SEM 0.2) cm/s
		End: mean (SD) ‐ at 3 months	SPECT: 46 (SEM 2) %	SPECT: 89 (SEM 9) ml	SPECT: 159 (SEM 12) ml	SPECT: 33 (SEM 4) %	Echocardiography: 5.2 (SEM 0.3) cm/s
		Mean (SD) change from baseline	SPECT: 5 ( SD 4.69) %	SPECT: ‐9 (SD 18.8) ml	SPECT: 1 (SD 28.1) ml	SPECT: ‐10 (SD 9.38) %	Echocardiography: ‐0.9 (SD 0.938) cm/s
	Control	Baseline: mean (SD)	SPECT: 42 (SEM 2) %	SPECT: 93 (SEM 8) ml	SPECT: 156 (SEM 9) ml	SPECT: 41 (SEM 4) %	Echocardiography: 5.2 (SEM 0.3) cm/s
		End: mean (SD) ‐at 3 months	SPECT: 44 (SEM 2) %	SPECT: 100 (SEM 10) ml	SPECT: 172 (SEM 12) ml	SPECT: 33 (SEM 4) %	Echocardiography: 5.2 (SEM 0.3) cm/s
		Mean (SD) change from baseline	SPECT: 2 (SD 4.69) %	SPECT: 7 (SD 28.14) ml	SPECT: 16 (SD 32.8) ml	SPECT: ‐8 (SD 14.07) %	Echocardiography: 0.0 (SD 0.469) cm/s
Ruan 2006	BMSC	Baseline: mean (SD)	Echocardiography: 53.37 (8.92) %	Echocardiography: 57.12 (18.66) ml	Echocardiography: 113.74 (23.24) ml	not measured	not measured
		End: mean (SD) ‐ 6 months	Echocardiography: 59.33 (12.91) %	Echocardiography: 52.43 (24.69) ml	Echocardiography: 111.71 (28.20) ml
		Mean (SD) change from baseline	not available	not available	not available
	Control	Baseline: mean (SD)	Echocardiography: 53.31 (5.84) %	Echocardiography: 62.09 (17.68) ml	Echocardiography:129.92 (32.71) ml	not measured	not measured
		End: mean (SD) ‐ 6 months	Echocardiography: 50.30 (8.30) %	Echocardiography: 81.18 (32.98) ml	Echocardiography: 159.20 (49.84) ml
		Mean (SD) change from baseline	not available	not available	not available
Schachinger 2006	BMSC	Baseline: mean (SD)	Angiogrpahy: 48.3 (9.2) %	Angiogrpahy: 67 (26) ml	Angiography: 128 (38) ml	not measured	Angiography: ‐1.54 (0.42)
		End: mean (SD) ‐ at 4 months	Angiogrpahy: 53.8 (10.2) %	Angiogrpahy: 67 (30) ml	Angiography: 141 (43) ml		Angiography: ‐1.17 (0.60)
		Mean (SD) change from baseline	Angiogrpahy: 5.5 (7.3) %	Angiogrpahy: 0.6 (19) ml	Angiography: 12 (31) ml		Angiography: 0.37 (0.53)
	Control	Baseline: mean (SD)	Angiogrpahy: 46.9 (10.4) %	Angiogrpahy: 75 (32) ml	Angiography: 139 (46) ml	not measured	Angiography: ‐1.54 (0.42)
		End: mean (SD) ‐ at 4 months	Angiogrpahy: 49.9 (13.0) %	Angiogrpahy: 80.6 (45) ml	Angiography: 153 (57) ml		Angiography: ‐1.27 (0.60)
		Mean (SD) change from baseline	Angiogrpahy: 3.0 (6.5) %	Angiogrpahy: 5.6 (22) ml	Angiography: 14 (33) ml		Angiography: 0.28 (0.52)
Meyer 2006b	BMSC	Baseline: mean (SD)	MRI: 50.0 (10.0) %	MRI: 43.0 (14.7) ml/m2 BSA.	MRI: 84.2 (17.2) ml/m2 BSA. Echocardiography: 114 (8) ml	not measured	MRI: 4.4 (1.9) mm
		End: mean (SD) ‐ at 6 and 18 months	MRI: 6 months: 56.7 (12.5) %; 18 months: 55.9 (14.7) %	MRI: 6 months: 42.4 (23.9) ml/m2 BSA; 18 months: 42.5 (25) ml/m2 BSA.	MRI: 6 months: 91.7 (26.0) ml/m2 BSA; 18 months: 90.3 (26.5) ml/m2 BSA Echocardiography: 6 months: 116 (7) ml; 18 months: 116 (7) ml		MRI: 6 months: 5.9 (2.5) mm; 18 months: 5.2 (2.2) mm
		Mean (SD) change from baseline	MRI: 6 months: 6.7 (6.5) %; 18 months: 5.9 (8.9) %	MRI: 6 months: ‐0.6 (14.9) ml/m2 BSA; 18 months: ‐0.5 (16.5) ml/m2 BSA.	MRI: 6 months: 7.6 (20.0) ml/m2 BSA; 18 months 6.1 (20.3) ml/m2 BSA.		MRI: 6 months: 1.5 (2.1) mm; 18 months: 0.8 (2.1) mm.
	Control	Baseline: mean (SD)	MRI: 51.3 (9.3) %	MRI: 40.6 (16.9) ml/m2 BSA.	MRI: 81.4 (16.9) ml/m2 BSA. Echocardiography: 106 (5) ml	not measured	MRI: 3.9 (1.8) mm
		End: mean (SD) ‐ at 6 and 18 months	MRI: 6 months: 52.0 (12.4) %; 18 months: 54.4 (13.0) %	MRI: 6 months: 42.6 (23.5) ml/m2 BSA; 18 months: 41.0 (24.7) ml/m2 BSA.	MRI: 6 months: 84.9 (21.9) ml/m2 BSA; 18 months: 85.0 (24.2) ml/m2 BSA. Echocardiography: 6 months: 106 (5) ml; 18 months: 109 (6) ml		MRI: 6 months: 4.9 (2.9) mm; 18 months: 4.5 (2.6) mm.
		Mean (SD) change from baseline	MRI: 6 months: 0.7 (8.1) %; 18 months: 3.1 (9.6) %	MRI: 2.0 (11.1) ml/m2 BSA; 18 months: 0.4 (12.5) ml/m2 BSA.	MRI: 6 months: 3.4 (11.1) ml/m2 BSA; 18 months: 3.6 (15.1) ml/m2 BSA. Echocardiography: 109 (6) ml		MRI: 6 months: 1.0 (2.5) mm; 18 months: 0.6 (2.7) mm.
Ge 2006	BMSC	Baseline: mean (SD) ‐ at 1 week	Echocardiography: 53.8 (9.2)%	not measured	LVEDd: Echocardiography: 52.5 (2.8) mm	not measured	SPECT: 21 (11)%
		End: mean (SD) ‐ at 6 months	Echocardiography: 58.6 (9.9)%	not measured	LVEDd: Echocardiography: 52.1 (3.2) mm		SPECT: 13 (10)%
		Mean (SD) change from baseline	Echocardiography: 4.8 (not reported)%	not measured	LVEDd: Echocardiography: ‐0.4 (not reported) mm		SPECT: ‐7 (not reported)%
	Contol	Baseline: mean (SD) ‐ at 1 week	Echocardiography: 58.2 (7.5)%	not measured	LVEDd: Echocardiography: 50.4 (6.0) mm	not measured	SPECT: 20 (14)%
		End: mean (SD) ‐ at 6 months	Echocardiography: 56.3 (3.5)%	not measured	LVEDd: Echocardiography: 55.2 (7.1) mm		SPECT: 17 (15)%
		Mean (SD) change from baseline	Echocardiography: ‐1.9 (not reported)%	not measured	LVEDd: Echocardiography: 4.8 (not reported) mm		SPECT: ‐2 (not reported)%
Penicka	BMSC	Baseline: mean (SD)	Echocardiography: 39 (6)%	Echocardiography: 98 (25) ml	Echocardiography: 163 (30) ml	SPECT: 41.4 (18.3)%	not measured
		End: mean (SD) ‐ at 4 months	Echocardiography: 45 (9)%	Echocardiography: 95 (28) ml	Echocardiography: 172 (34) ml	SPECT: 30.5 (16.1)%
		Mean (SD) change from baseline	Echocardiography: 6 (9.6)%	3.10% (SD not reported)	5.50% (SD not reported)	SPECT: ‐10.9 (12.84)%
	Control	Baseline: mean (SD)	Echocardiography: 39 (4)%	Echocardiography: 98 (23) ml	Echocardiography: 162 (30) ml	SPECT: 47.5 (20.8)%	not measured
		End: mean (SD) ‐ at 4 months	Echocardiography: 47 (7)%	Echocardiography: 96 (28) ml	Echocardiography: 174 (29) ml	SPECT: 35.3 (17.2)%
		Mean (SD) change from baseline	Echocardiography: 8 (12.8)%	2.00% (SD not reported)	7.40 % (SD not reported).	SPECT: ‐12.2 (14.36)%
Saurez de Lezo 2007	BMSC	Baseline: mean (SD)	Angiography: 37 (5)%	Angiography: 89 (27) ml/m2	Angiography: 142 (35) ml/m2	not measured	Angiography: 33 (12)%
		End: mean (SD) ‐ at 3 months	Angiography: 58 (9)%	Angiography: 61 (19) ml/m2	Angiography: 134 (29) ml/m2		Angiography: 8 (10)%
		Mean (SD) change from baseline	Angiography: 20 (8)%	Angiography: not reported	Angiography: not reported		Angiography: ‐20 (15)%
	Control	Baseline: mean (SD)	Angiography: 39 (6)%	Angiography: 83 (25) ml/m2	Angiography: 140 (30) ml/m2	not measured	Angiography: 27 (13)%
		End: mean (SD) ‐ at 3 months	Angiography: 45 (8)%	Angiography: 87 (35) ml/m2	Angiography: 159 (43) ml/m2		Angiography: 16 (9)%
		Mean (SD) change from baseline	Angiography: 6 (10)%	Angiography: not reported	Angiography: not reported		Angiography: ‐6 (3)%
BMSC, bone marrow‐derived stem cells; BSA, bovine serum albumin; LVEDV, left ventricular end‐diastolic volume; LVEF, left ventricular ejection fraction; LVESV, left ventricular end‐systolic volume; MRI, magnetic resonance imaging; SD, standard deviation; SEM, standard error of the mean; SPECT, single photon emission computed tomography.

Table 7. Scientific Outcomes: Actual Data Table

Ir a la tabla de la revisión

Comparison 1. Stem cells compared to no stem cells

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality Show forest plot	5	391	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.22, 1.76]

2 Incidence of reinfarction Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Immediate follow‐up (<30 days)	1	50	Risk Ratio (M‐H, Random, 95% CI)	0.33 [0.01, 7.81]
2.2 Short term follow‐up (>30 days ‐4 months)	3	148	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.12, 2.96]
2.3 Long term follow‐up (12 months)	1	204	Risk Ratio (M‐H, Random, 95% CI)	0.08 [0.00, 1.37]
3 Incidence of restenosis Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 Short term follow‐up (>30 days ‐ 6 months)	5	290	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.68, 1.80]
3.2 Long term follow‐up (12 months)	1	67	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.13]
4 Incidence of hospital readmission Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 Short term follow‐up (>30 days ‐ 6 months)	3	187	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.25, 1.52]
4.2 Long term follow‐up (12 months)	1	204	Risk Ratio (M‐H, Random, 95% CI)	0.15 [0.01, 2.78]
5 Incidence of target vessel revascularisation Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Short term follow‐up (<30 days ‐ 6 months)	2	77	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.19, 1.62]
5.2 Long term follow‐up (12 ‐ 18 months)	2	264	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.42, 1.20]
6 LVESV mean change from baseline to end of study (>30 days ‐ 6 months) Show forest plot	6		Mean Difference (IV, Random, 95% CI)	Subtotals only

6.1 measured by MRI	3	170	Mean Difference (IV, Random, 95% CI)	‐3.81 [‐8.72, 1.09]
6.2 measured by ventricular angiography	1	187	Mean Difference (IV, Random, 95% CI)	‐5.0 [‐10.90, 0.90]
6.3 measured by SPECT	2	88	Mean Difference (IV, Random, 95% CI)	‐13.24 [‐23.62, ‐2.85]
7 LVESV comparison of mean end of study data (Echocardiography): 3 trials Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

7.1 measured at 6 months follow‐up	3	102	Mean Difference (IV, Random, 95% CI)	‐6.89 [‐22.51, 8.74]
8 LVESV comparison of mean end of study data (Echocardiography): exploring heterogeneity ‐ baseline LVEF Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

8.1 Mean LVEF at baseline <50%	1	24	Mean Difference (IV, Random, 95% CI)	‐1.0 [‐23.72, 21.72]
8.2 Mean LVEF at baseline =/>50%	2	78	Mean Difference (IV, Random, 95% CI)	‐11.75 [‐39.45, 15.95]
9 LVEDV mean change from baseline to end of study (>30 days to 6 months) Show forest plot	8		Mean Difference (IV, Random, 95% CI)	Subtotals only

9.1 Measured by MRI	5	298	Mean Difference (IV, Random, 95% CI)	‐1.41 [‐5.10, 2.28]
9.2 Measured by left ventricular angiography	1	187	Mean Difference (IV, Random, 95% CI)	‐2.0 [‐11.18, 7.18]
9.3 Measured by SPECT	3	188	Mean Difference (IV, Random, 95% CI)	‐11.14 [‐19.64, ‐2.64]
10 LVEDV comparison of mean end of study data (Echocardiography) : 4 trials Show forest plot	5		Mean Difference (IV, Random, 95% CI)	Subtotals only

10.1 measured by 6 months follow‐up	5	261	Mean Difference (IV, Random, 95% CI)	0.50 [‐10.23, 11.24]
11 LVEDV comparison of mean end of study data (Echocardiography): exploring heterogeneity ‐ timing of SCT Show forest plot	5		Mean Difference (IV, Random, 95% CI)	Subtotals only

11.1 SCT within 24‐48 hours following AMI	1	20	Mean Difference (IV, Random, 95% CI)	‐47.49 [‐82.23, ‐12.75]
11.2 SCT =/> 5 days following AMI	4	241	Mean Difference (IV, Random, 95% CI)	6.64 [3.48, 9.79]
12 Infarct size mean change from baseline to end of study (>30 days ‐ 6 months) Show forest plot	6		Mean Difference (IV, Random, 95% CI)	Subtotals only

12.1 Measured by MRI	3	186	Mean Difference (IV, Random, 95% CI)	‐1.71 [‐6.62, 3.20]
12.2 Measured by SPECT	4	212	Mean Difference (IV, Random, 95% CI)	‐1.99 [‐5.11, 1.12]
13 Infarct size mean change from baseline to end of study (MRI): exploring heterogeneity ‐ BMSC dose Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

13.1 Dose BMSC: </= 1 x 10 (8) cells	1	100	Mean Difference (IV, Random, 95% CI)	3.60 [‐1.28, 8.48]
13.2 Dose BMSC: </= 1 x 10 (9) cells	2	100	Mean Difference (IV, Random, 95% CI)	‐4.07 [‐7.19, ‐0.96]
14 Infarct size mean change from baseline to end of study (MRI): exploring heterogeneity ‐ baselineLVEF Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

14.1 Baseline measures taken prior to BMSC infusion	1	60	Mean Difference (IV, Random, 95% CI)	‐2.30 [‐6.45, 1.85]
14.2 Baseline measures taken after BMSC infusion	2	126	Mean Difference (IV, Random, 95% CI)	‐1.16 [‐10.07, 7.75]
15 Wall motion score mean change from baseline to end of study (>30 days ‐ 6 months) Show forest plot	6		Mean Difference (IV, Random, 95% CI)	Subtotals only

15.1 Measured by MRI	1	60	Mean Difference (IV, Random, 95% CI)	0.5 [‐0.67, 1.67]
15.2 Measured by echocardiography	3	146	Mean Difference (IV, Random, 95% CI)	‐0.38 [‐1.11, 0.34]
15.3 Measured by left ventricular angiography	2	207	Mean Difference (IV, Random, 95% CI)	‐6.12 [‐19.84, 7.59]
16 Wall motion score mean change from baseline to end of study (Echocardiography): exploring heterogeneity ‐G‐CSF Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

16.1 Co‐intervention received: G‐CSF	1	58	Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.14, 0.02]
16.2 No co‐intervention	2	88	Mean Difference (IV, Random, 95% CI)	‐0.7 [‐1.09, ‐0.31]
17 LVEF mean change from baseline to end of study (>30 days ‐6 months) Show forest plot	9		Mean Difference (IV, Random, 95% CI)	Subtotals only

17.1 measured by left ventricular angiography	3	247	Mean Difference (IV, Random, 95% CI)	3.69 [0.57, 6.81]
17.2 measured by SPECT	3	188	Mean Difference (IV, Random, 95% CI)	1.83 [0.06, 3.60]
17.3 measured by MRI	5	298	Mean Difference (IV, Random, 95% CI)	2.19 [‐1.15, 5.53]
18 LVEF comparison of mean end of study data (Echocardiography): 4 trials. Show forest plot	5		Mean Difference (IV, Random, 95% CI)	Subtotals only

18.1 measured at 6 months follow‐up	5	222	Mean Difference (IV, Random, 95% CI)	2.16 [‐0.92, 5.25]
19 LVEF mean change from baseline to end of study (MRI): exploring heterogeneity ‐ baseline pre SCT Show forest plot	5		Mean Difference (IV, Random, 95% CI)	Subtotals only

19.1 Baseline meansures taken prior to BMSC infusion	3	170	Mean Difference (IV, Random, 95% CI)	4.02 [0.86, 7.18]
19.2 Baseline measures taken after BMSC infusion	2	128	Mean Difference (IV, Random, 95% CI)	‐0.33 [‐5.81, 5.16]
20 LVEF mean change from baseline to end of study ( MRI): exploring heterogeneity ‐ BMSC dose Show forest plot	5		Mean Difference (IV, Random, 95% CI)	Subtotals only

20.1 Dose BMSC: </= 1 x 10 (8) cells	1	88	Mean Difference (IV, Random, 95% CI)	‐3.10 [‐6.15, ‐0.05]
20.2 Dose BMSC: </= 1 x 10 (9) cells	2	100	Mean Difference (IV, Random, 95% CI)	1.92 [‐0.48, 4.32]
20.3 Dose BMSC: </= 1 x 10 (10) cells	2	110	Mean Difference (IV, Random, 95% CI)	5.74 [2.78, 8.71]
21 LVEF mean change from baseline to end of study (Angiography): exploring heterogeneity ‐ comparator Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

21.1 Comparator: heparanised saline	2	60	Mean Difference (IV, Random, 95% CI)	7.39 [‐4.20, 18.98]
21.2 Comparator: 'placebo'	1	187	Mean Difference (IV, Random, 95% CI)	2.5 [0.52, 4.48]
22 LVEF mean change from baseline to emd of study (Angiography): exploring heterogeneity ‐ timing of SCT Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Subtotals only

22.1 SCT within 24 ‐ 48 hours following AMI	1	40	Mean Difference (IV, Random, 95% CI)	2.10 [0.51, 3.69]
22.2 SCT =/> 5 days following AMI	2	207	Mean Difference (IV, Random, 95% CI)	7.58 [‐3.61, 18.77]

Comparison 1. Stem cells compared to no stem cells

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