A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesen… (NCT01484574) | Clinical Trial Compass
CompletedPhase 2
A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease
India90 participantsStarted 2012-01
Plain-language summary
This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.
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, who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients)
* Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 50 mm Hg or TcPO2 ≤ 40 mmHg in the foot of the study limb
* 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 transmetatarsal 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 mel…
What they're measuring
1
Relief of the rest pain
Timeframe: 6 months
2
Healing of ulcerations or reduction of ulcer area in the target limb
Timeframe: 6 months
3
Relief of the rest pain
Timeframe: 24 months
4
Healing of ulcerations or reduction of ulcer area in the target limb