CHART-1 (Congestive Heart failure Cardiopoietic Regenerative Therapy)

• Research type

  Research Study

• Full title

  Efficacy and Safety of Bone Marrow-Derived Mesenchymal Cardiopoietic Cells (C3BS-CQR-1) for the treatment of chronic advanced ischemic Heart Failure

• IRAS ID

  110635

• Contact name

  Jonathan Hill

• Sponsor organisation

  Cardio3 BioSciences SA

• Eudract number

  2011-001117-13

• Research summary

  This is a prospective, multi-center, randomised, sham-controlled, double blind study (patient and evaluator) to evaluate the efficacy and safety of bone marrow-derived mesenchymal cardiopoietic cells for the treatment of chronic advanced ischemic heart failure. Patient with chronic advanced symptomatic heart failure secondary to ischemic cardiomyopathy meeting all of the eligibility criteria will be selected in approximately 35-45 sites in Europe and Asia. All patients will have a bone marrow harvest performed (iliac crest).The bone marrow is sent to C3BS laboratory where the cells will be expanded and differentiated in order to select the cardiopoietic cells only. Patient will be randomised either to the treatment group (standard of care and injection procedure of C3BS-CQR-1) either to the control group (standard of care and sham procedure (which means they will undergo a catheter procedure without any injection).Clinical follow up (6 min walk test, quality of life questionnaire, blood analyses), ECG and echocardiography for a period of 2 years(post-procedure, 4, 13, 26, 39, 52 and 104 weeks)for all patients from both groups.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  12/LO/1640

• Date of REC Opinion

  7 Feb 2013

• REC opinion

  Further Information Favourable Opinion