Intracoronary Transplantation of Autologous Bone Marrow-Derived Mononuclear Cells for Idiopathic Dilated Cardiomyopathy inPediatric: A Phase I/II, Randomized, Single Blind Clinical Trial

سال انتشار: 1397
نوع سند: مقاله کنفرانسی
زبان: انگلیسی
مشاهده: 353

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شناسه ملی سند علمی:

NSCMRMED03_274

تاریخ نمایه سازی: 30 دی 1397

چکیده مقاله:

Background and Aim: Dilated cardiomyopathy as the most commonform of cardiomyopathy is a rare but life-threatening disorder in children.Despite the developing in the medical and surgical treatment, standardtreatments may stabilize the condition, but will not restore heart functionto its previous condition. Therapy remains complex and expensive. Forsome not all children the heart transplantation is the only option. Cellbasedtherapies offer an innovative approach to reverse cardiac functiontowards normal, possibly reducing the need for aggressive therapies andcardiac transplantation. Methods: In this study children with idiopathic dilated cardiomyopathywere enrolled at Shahid Rajaie Cardiovascular, Medical & ResearchCenter in collaboration with Royan Institute. According to the inclusionand exclusion criteria of the trial, 24 patients with left ventricularejection fraction less than 45% who resistance to the standard medicaltherapy signed a consent form and was randomly allocated in 2 groupsincluding BM-derived mononuclear (BMMNC) (n=12) and control(n=12). Only the MNC group underwent the bone marrow aspiration andintracoronary injection. We followed all of the patients at 2 weeks, 1, 2,4 and 6 months after transplantation for cell therapy group or registrationfor placebo by physical examination, laboratory tests and imaging suchas echocardiography, CXR, and CMR. (ClinicalTrials.gov Identifier:NCT02256501)Results: The mean (SD) age of 24 patients was 8.0 (5.2) years in controland 9.4 (2.9) in MNC. 28.6% and 62.5% of participants were female incontrol and MNC group, respectively. We have no significant differencesin baseline characteristics between groups. Almost 583×106 mononuclearcells were injected to the coronary artery during less than 6 hours ofautologous bone marrow aspiration for MNC group. The primary outcomewas safety assessment. No procedure-related unexpected adverse eventsoccurred. The MNC group patients showed an improvement with respectto New York Heart Association classification (greater than or equal to 1)and reducing in brain natriuretic peptide serum levels. Although LVEFimprovement, relative to baseline was significant in the BMMNC group.Conclusion: In this clinical trial, intracoronary injection of BMMNCwas feasible and safe. Additionally, transplantation of BM-derivedmononuclear cells compared to the control group can improve theimaging, laboratory and clinical cardiac function.

کلیدواژه ها:

Idiopathic dilated cardiomyopathy ، Bone marrow-derived mononuclear cells ، Cell therapy

نویسندگان

M Mahdavi

Department of Pediatric Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of MedicalSciences, Tehran, Iran

Hoda Madani

Department of Regenerative Medicine at the Cell Science Research Center, Royan Institute for Stem Cell Biology andTechnology ACECR, Tehran, Iran

K Vahidshahi

Department of Pediatric Cardiology, Rajaie Cardiovascular Medical and Research Center, Iran University of MedicalSciences, Tehran, Iran

H Pouraliakbar

Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran