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A randomized study of autologous bone marrow–derived stem cells in pediatric cardiomyopathy *


Bone marrow mononuclear cell fraction has been used as therapy for dilated cardiomyopathy in adults. Although case series are reported, there are no randomized controlled studies in children.


We designed a randomized, crossover, controlled pilot study to determine safety and feasibility of intracoronary stem cell therapy in children. The primary safety end-point was freedom from death and transplantation or any complication that could be considered related to bone marrow injection or anesthesia (e.g., infection, malignancy, anaphylaxis, renal deterioration). Other end-points were magnetic resonance imaging measurements and N-terminal prohormone brain natriuretic peptide. Participants included 10 children (mean age 7.2 years; range, 2.2–14.1 years; 6 boys) with cardiomyopathy (New York Heart Association/Ross Classification II–IV). Patients were crossed over at 6 months.


The original protocol was completed by 9 patients. The safety end-point was achieved in all. Ratio of the geometric means for treatment effect adjusting for baseline was assessed for end-diastolic and end-systolic volumes (EDV, ESV): 0.93 for EDV (95% confidence interval 0.88–0.99, p = 0.01), indicating EDV was on average 7% lower in patients after stem cell treatment, and 0.90 for ESV (95% confidence interval 0.82–1.00, p = 0.05), indicating ESV was on average 10% lower after stem cell treatment compared with placebo. The primary efficacy end-point ejection fraction was not met.


Bone marrow mononuclear cell therapy for cardiomyopathy is feasible and safe in children. Left ventricular volumes were significantly reduced 6 months after stem cell injection compared with placebo, which may reflect reverse remodeling.

* Legal Disclaimer: Chelation and Hyperbaric Therapy, Stem Cell Therapy, and other treatments and modalities mentioned or referred to in this web site are medical techniques that may or may not be considered “mainstream”. As with any medical treatment, results will vary among individuals, and there is no implication or guarantee that you will heal or achieve the same outcome as patients herein.

As with any procedure, there could be pain or other substantial risks involved. These concerns should be discussed with your health care provider prior to any treatment so that you have proper informed consent and understand that there are no guarantees to healing.

THE INFORMATION IN THIS WEBSITE IS OFFERED FOR GENERAL EDUCATIONAL PURPOSES ONLY AND DOES NOT IMPLY OR GIVE MEDICAL ADVICE. No Doctor/Patient relationship shall be deemed to have arisen simply by reading the information contained on these pages, and you should consult with your personal physician/care giver regarding your medical treatment before undergoing any sort of treatment or therapy.

Published on 10-17-2017
Authors: E. Sian Pincott PhD, MRCPCH, Deborah Ridout MSc, Margaret Brocklesby BSC, Angus McEwan FRCA, Vivek Muthurangu MD, MRCPCH, Michael Burch MD, FRCP, FRCPCH