A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buer… (NCT03056742) | Clinical Trial Compass
WithdrawnPhase 2
A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
Stopped: Form 46 from DCGI for the manufacturing \& commercial marketing of Stempeucel® directs Stempeutics to conduct PMS study. Hence this study is being terminated.
India0Started 2017-02-20
Plain-language summary
This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Buerger's disease as diagnosed by Shionoya criteria
✓. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.
✓. Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;
✓. Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (patients with wet gangrene must undergo wound debridement / amputation before screening) .
✓. Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis (patients should have at least one measureable ulcer), who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) .
✓. ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
✓. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent and video consent, abide by the study requirements, and agree to return for required follow-up visits.
Exclusion criteria
✕. Patients with CLI indicated for major amputation during screening
✕. Atherosclerotic PAD
✕. Ulcers with exposure of tendon and/bone in the shin region.
✕. Previous above trans metatarsal amputation in study limb