Health Condition 1: null- Limb Ischemia
Conditions
Interventions
Intervention1: stem cell Therapy: 40- 50 million cells
Control Intervention1: Standard Treatment:
Sponsors
Department of Biotechnology New Delhi
Eligibility
Inclusion criteria
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 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 d) A resting ankle brachial pressure index
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the composite of clinical status and improvement in TcO2 and improvement in ABITimepoint: 1, 3 and 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in the grade of collaterals or Improvement in the visualization of distal run-off vesselsTimepoint: 1, 3 and 6 month | — |
Countries
India
Contacts
Public ContactDr Sanjiv Sharma
All India Institute of Medical Sciences
Outcome results
None listed