Safety and efficacy of patient`s own stem cells in prevention of amputation in patients with chronic critical limb due to obstruction of blood flow in arteries of the affected limb(s).
- Registration Number
- CTRI/2009/091/000954
- Lead Sponsor
- Department of Biotechnology(DBT) Goverment of India, CGO coplex, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
? Age and sex: between 18 and 70 years of age, either gender.
? Willingness to sign the written informed consent
? Peripheral arterial occlusive disease of the lower limb, either classified as grade III or IV ischemia according to Fontaine classification (Table 3), or clinical evidence of rest pain, ischemic ulcers, gangrene of the lower extremities, with ischemic lesion not extending proximal to the forefoot, where trans-metatarsal amputation would not be possible. The eligibility of patient will be decided jointly by 2 surgeons from the panel (Appendix 1).
? Peripheral arterial disease for which surgical or radiological intervention is either not possible or has failed with no possibility of its repetition (Appendix 1)
. TcPO2 <40 mmHg at the dorsum of foot in supine position TcPO2 >40 mm of Hg is acceptable -In patients fulfilling all the inclusion criteria and decided by a team of 2 surgeons.
Subject will be eligible for the study only if all of the above criteria are fulfilled.
? Unwilling to sign informed consent
? Life expectancy of less than 1 year due to any other co-existing disease assessed by 2 surgeons
? History of alcohol/drug dependence with in 3 months
? Malignant neoplasm or history of malignant neoplasm in the past 5 years
? Severe retinopathy i.e. any gross changes in the optic disc, macula or retinal blood vessels
? Severe nephropathy (serum creatinine >3.0 mg/dl)
? Pregnancy or intent to conceive in the next 2 years
? Hb A1C > 7.0 at the time of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ?Reduction of risk of major amputation (Above Knee [AK] or below knee [BK]) up to 6 months from commencement of therapy<br>?Major adverse events up to 6 months from commencement of therapy<br>Timepoint:
- Secondary Outcome Measures
Name Time Method ?Reduction in Rest pain recorded as a continuous variable of 0-10 on numerical rating scale, <br>?Healing of ischemic ulcers recorded as a binary variable ?yes / no.<br>?Pain at injection site and its duration recorded on a numeric rating scale of 0 to 10. <br>? TcPO2 as a continuous variable.<br>?Mean ankle-brachial index (ABI) as a continuous variable <br>Timepoint: