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. 2021 Jul 21;2021(7):CD013433. doi: 10.1002/14651858.CD013433.pub2

Xiao 2017.

Study characteristics
Methods Study design: RCT
Parallel groups (3; arm 1: IC administration of BMMC, arm 2: IC administration of BMSC, and arm 3: equal volume normal saline)
Open label
Single centre
Country: China
Duration: 12 months
Participants 55 participants (BMMC arm 16, BMSC arm 17, control arm 20)
Period (recruitment): March 2010 through June 2011
Inclusion criteria: people with DCM and reduced LVEF < 40%, aged 18–75 years, NYHA functional class II–IV, proportion of fixed defects < 40%, normal coronary arteries, and signed informed consent
Exclusion criteria: coronary artery disease based on coronary angiography prior to cell delivery, ventricular arrhythmias, and any comorbidities with an impact on survival.
Baseline characteristics

  • Sex (male): BMMC 56.3% vs BMSC 70.6% vs control 70.0%

  • Age (years), mean: BMMC 49.5 (SD 11.6) vs BMSC 51.6 (SD 12.2) vs control 54.4 (SD 11.6)

  • LVEF (%), mean: BMMC 33.1 (SD 3.9) vs BMSC 34.1 (SD 3.6) vs control 33.7 (SD 4.0)

  • LVEDD (mm), mean: BMMC 64.9 (SD 5.7) vs BMSC 65.2 (SD 5.5) vs control 64.7 (SD 3.9)
Interventions Intervention group 1: BMMC

  • Cell origin: bone marrow

  • Cell collection location: bilateral posterior superior iliac spines (80–100 mL)

  • Type of cells infused: mononuclear, autologous

  • Mean volume/number administered: 5.1 (SD 2.0) × 108 cells

  • Cell mobilization: no

  • Delivery route: IC

  • Number of cell infusions: apparently single


Intervention group 2: BMSC

  • Cell origin: bone marrow

  • Cell collection location: bilateral posterior superior iliac spines (80–100 mL)

  • Type of cells infused: mesenchymal, autologous

  • Mean volume/number administered: 4.9 (SD 1.7) × 108 cells

  • Cell mobilization: no

  • Delivery route: IC

  • Number of infusions: single


Control group: placebo

  • Equal volume normal saline (sham SCT)


Study included in Comparison 1 (STC vs control) and Comparison 3 (STC vs SCT)
Outcomes Outcomes included in review

  • Procedural complications (defined as any new‐onset ventricular arrhythmia, conduction disturbance, distal embolization, thrombus formation, and injury of the coronary artery related to the cell injection procedure)

  • Change in NYHA class

  • Change in LVEF

  • MACE (consisting in any of the following: procedural complications, any new onset arrhythmia, haemodynamic instability, and death by any cause)


Other outcomes reported

  • Change in LVEDD
Notes Not registered at ClinicalTrials.gov.
Funding: not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details provided.
Allocation concealment (selection bias) Unclear risk No details provided.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Control group consisted of sham SCT.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Echocardiography examinations were performed at baseline and the 3‐month and 12‐month follow‐ups by an independent echocardiographer who was blinded to the participant grouping. Similarly, NYHA data were accessed by a blinded observer according to the standard clinical protocol."
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "One patient in the BMMC group and 1 in the BMSC group were lost to follow‐up, and 3 cases were lost to follow‐up in the control group."
According to Table II, at 3 months, 15 (1 lost to follow‐up) in BMMC arm, 16 (1 lost to follow‐up) in BMSC arm, and 18 (2 lost to follow‐up) in placebo arm were analysed, and at 12 months there were 14 (2 lost to follow‐up) in BMMC arm, 16 (1 lost to follow‐up) in BMSC arm, and 15 (5 lost to follow‐up) in placebo arm. The paper also stated that data from participants who were lost during follow‐up were excluded from the analysis.
Selective reporting (reporting bias) Unclear risk Protocol not reported.

6MWT: 6‐minute walk test; BMA: bone marrow aspiration; BMC: bone marrow cell; BMMC: bone marrow mononuclear cell; BNP: brain natriuretic peptide; CK: creatine kinase; DCM: dilated cardiomyopathy; EF: ejection fraction; EQ5D: European Quality of Life‐5 Dimensions; FDG‐PET: fluorodeoxyglucose‐positron emission tomography; G‐CSF: granulocyte‐colony stimulating factor; h: hour; HF: heart failure; hMSC: human mesenchymal stem cell; HRQoL: health‐related quality of life; IC: intracoronary; KCCQ: Kansas City Cardiomyopathy Questionnaire; LV: left ventricle; LVEDD: left ventricular end‐diastolic diameter; LVEDV: left ventricular end‐diastolic volume; LVESV: left ventricular end‐systolic volume; LVEF: left ventricular ejection fraction; MACE: major adverse cardiovascular event; min: minute; MLHFQ: Minnesota Living with Heart Failure Questionnaire; mph: miles per hour; NIDCM: non‐ischaemic dilated cardiomyopathy; NT‐proBNP: N‐terminal pro‐brain natriuretic peptide; NYHA: New York Heart Association; RCT: randomized controlled trial; SC: subcutaneous; SD: standard deviation; VE/VCO2: ventilation/volume of exhaled carbon dioxide; VO2peak: peak oxygen uptake; WHO: World Health Organization.