Cell Repair in Heart Failure
Procedure: Retrograde coronary venous delivery of cells.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase I/II, Randomised, Double-blind, Placebo Controlled, Single-centre Study of Bone Marrow Mononuclear Cells by Percutaneous Retrograde Coronary Venous Delivery to Patients With Ischaemic Heart Failure and no Standard Revascularisation Options.|
- Safety: up to one year
- Co-primary endpoints at 180 Days
- Perfusion (MIBI SPECT)
- Function (CMR)
- Efficacy: at 180 days
- Perfusion (CMR)
- Function (ECHO, SPECT)
- Exercise (VO2 Max)
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||December 2008|
|Estimated Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
- Evaluate the safety of a single administration of bone marrow mononuclear cells by retrograde coronary venous delivery.
- Evaluate the bioactivity of bone marrow mononuclear cells in mediating increased perfusion in viable underperfused areas of myocardium.
- Evaluate the ability of bone marrow mononuclear cells to improve myocardial function specifically regional wall motion and cardiac synchronisation.
- Evaluate the use of potential bioactivity assays and clinical outcomes for assessing bone marrow mononuclear cell- induced myocardial changes.
A phase I/II, randomised, double-blind, placebo controlled, single-centre study of bone marrow mononuclear cells by percutaneous retrograde coronary venous delivery to patients with ischaemic heart failure and no standard revascularisation options.
Patients with symptomatic ischaemic heart failure, not amenable to conventional revascularisation strategies (PCI, CABG, LVAD) or transplantation.
The results of the screening procedures will be compiled and submitted to an independent interventional cardiologist and cardiac surgeon who are not associated with the study for consideration for enrolment. It will be the independent reviewer's responsibility to confirm eligibility prior to a patient participating in the study.
Autologous bone marrow mononuclear, the first 6 safety and feasibility patients (open-labelled) will receive a sub-population of Indium-111 labelled cells to assess feasibility of delivery. The remaining patients will either receive Active: Bone marrow mononuclear cells and 5 % HSA Placebo: 5% HSA
Retrograde coronary venous delivery The total dose of bone marrow mononuclear cells or placebo will be divided into two, each administered as a 10ml bolus into a selective coronary veins. There will be significant patient heterogeneity regarding size of ischaemic viable territory present and anatomy of venous system. We aim to treat two veins, individual SPECT and venogram results will be used to direct the venous anatomy to be targeted. An attempt will be made to cover as large an area as possible of a patient's ischaemic viable territory. The total dose of cells will remain constant between patients.
The first 6 patients will receive cells as an adjunct to Cardiac resynchronization Therapy and ICD. An external Data Safety and Monitoring Board has also been appointed to oversee this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285454
|The Department of Gene Therapy, The National Heart and Lung Institute, Imperial College London and The Royal Brompton Hospital.|
|London, Middlesex, United Kingdom, SW3 6LR|
|Principal Investigator:||Eric WF Alton||The Department of Gene Therapy, The NHLI Imperial College London|
|Principal Investigator:||Jonathan R Clague||The Royal Brompton Hospital London|