Clinical evaluation of the safety and effectiveness of autologous bone marrow aspirate concentrate (BMAC) for the treatment of non reconstructable critical limb ischemia due to peripheral arterial occlusive disease

Subjects

Study Phase

Venue

60

Single phase, prospective, single center

SRI RAMACHANDRA MEDICAL CENTRE, Chennai

Results: Limb salvage rate for all subjects at week 26 was 86.4% and amputation rate was 13.5%.

DISCUSSION : Based on the results of the final analysis, it can be concluded that the BMAC obtained from Harvest Bone Marrow Aspirate Concentrate System for the treatment of non reconstructable Critical Limb Ischemia due to peripheral arterial occlusive disease is safe and has shown to improve the quality of life. It has also given a proof of its efficacy in reducing perception of pain and improvement in various objective measurements like TcPO2, ABI and pain free walking distance. Also, this study has shown that, both the methods of deliveries of BMAC are equally effective and safe.

A randomized, double-blind, placebo-controlled phase iii study for autologous bone marrow cell transplantation in Critical Limb Ischemia: the BONe Marrow Outcomes Trial in Critical Limb Ischemia (BONMOT- CLI).

Subjects

Study Phase

Venue

90

Randomized, placebo - controlled

VASCULAR CENTER OF FRANZISKUS HOSPITAL, Berlin

Results:: The Treatment Group Significant Improvement In Perfusion, Quality Of Life And Pain Free Walking Distance

DISCUSSION : The treatment group showed a 100 percent improvement in perfusion (0.3 to 0.62) as measured by the ankle-brachial index (“ABI”) compared to the control group, which exhibited only a non-significant change in ABI (0.4 to 0.5). Increased blood supply was also confirmed by an increase of oxygen pressure in the foot, which showed the treatment group having an 18-point increase compared to a seven-point increase in the control group. The treatment group also showed an improvement in a standardized quality-of-life assessment over the control group, and also a significant improvement of 30 meters in pain-free walking compared to an increase of 10 meters for the control group.

Feasibility study of the safety and activity of autologous bone marrow aspirate concentrate (bmac) for the treatment of non reconstructable critical limb ischemia due to peripheral arterial occlusive disease

Subjects

Study Phase

Venue

5

Single phase, prospective, multi center

SRI RAMACHANDRA MEDICAL CENTRE, Chennai

feasibility study of autologous concentrated bone marrow nucleated cell therapy for ischemic congestive heart failure patients undergoing treatment with coronary artery bypass grafting surgery

Subjects

Study Phase

Venue

48

Single phase, prospective, multi center

MEDANTA MEDICITY, Delhi

A randomized, single blind, single centre, placebo controlled, single dose, phase i / ii study to evaluate the safety and efficacy of allogenic cord blood infusion in patients with type i diabetes mellitus

Subjects

Study Phase

Venue

30

Single phase, prospective, Single center

M.V.HOSPITAL FOR DIABETES, Chennai

A phase i, prospective, pilot, open label, single center study to evaluate the safety of autologous cord blood infusion along with mannitol in children with cerebral palsy

Subjects

Study Phase

Venue

12

Single phase, prospective, Single center

FORTIS MALAR HOSPITALS, Chennai

Comparative study of efficacy of autologous bone marrow aspirate concentrate (bmac) cell therapy with standard treatment for burns wound healing

Subjects

Study Phase

Venue

12

Single phase, Randomized, Controlled,
Single center

KILPAUK MEDICAL COLLEGE, Chennai

Dr. A.P.J. Abdul Kalam has inaugurated TRICell - Stem Cell Center on 28th November 2007, Wednesday at 4:00pm