Safety and efficacy of autologous stem cells in prevention of amputation in patients with chronic critical limb ischemia

Department of Biotechnology(DBT) Goverment of India, CGO coplex, New Delhi0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•? 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

发起方

Department of Biotechnology(DBT) Goverment of India, CGO coplex, New Delhi