A clinical trial to evaluate the effect of bone marrow derived stem cell in diseases Limb Ischemia

Phase 1/2

Completed

• Conditions: Limb Ischemia

• Registration Number: CTRI/2010/091/000565
• Lead Sponsor: Department of Biotechnology New Delhi

Brief Summary

This is randomised controlled clinical trial to evaluate the feasibility, safety and therapeutic efficacy of angiogenesis induced by intra-arterial delivery of stem cells derived from autologous bone marrow in patients with critical limb ischemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-15
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1)Clinical a)Rest pain requiring analgesia for > 2 weeks, and/or non healing ischemic ulcers b)Absent /weak peripheral pulses c)No response to smoking cessation for at least 3 months prior to evaluation d)Not suited for surgical/ endovascular revascularization d)Unilateral or bilateral involvement e) Claudication distance of <200 meters.
• 2. Hemodynamic a) Doppler study showing an occluded superficial femoral, popliteal, or infra-popliteal artery, with no or poor distal flow as evidenced by a monophasic, low velocity, collateralized flow pattern.
• b) Contrast-enhanced magnetic resonance and digital subtraction angiography demonstrating the site of occlusion, status of distal run-off and the extent of collateralization c) Ankle systolic pressure < 50 mm Hg d) A resting ankle brachial pressure index <0.5 in the affected limb on 2 consecutive examinations done at least 2 days apart (normal range, 0.9-1.1).

Exclusion Criteria

a)Poorly controlled diabetes mellitus b)Evidence of a malignancy during the last 5 year c)Renal dysfunction or other contraindication to injection of contrast media d)Continued smoking e)Limitation to exercise due to any reason other than claudication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the composite of clinical status and improvement in TcO2 and improvement in ABI	1, 3 and 6 month

Secondary Outcome Measures

Name	Time	Method
Improvement in the grade of collaterals or Improvement in the visualization of distal run-off vessels	1, 3 and 6 month

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Sanjiv Sharma

Principal investigator

01126594759

meetisv@yahoo.com