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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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) .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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
. Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
. Patients with gait disturbance for reasons other than CLI
. Diagnosis of diabetes mellitus (type 1 or type 2)
. Patients having left ventricular ejection fraction \< 35%