Health Condition 1: I731- Thromboangiitis obliterans [Buergers disease]
Conditions
Interventions
Intervention1: stempeucel®: Stempeucel® consists of ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells. Stempeucel® will be injected at a dose of 2 million cells/kg body w
Sponsors
Stempeutics Research Pvt Ltd
Ecron Acunova
Eligibility
Inclusion criteria
Inclusion criteria: a. Buergerâ??s disease as diagnosed by Shionoya criteria b. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs. c. Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5; d. 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). e. 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). f. ABPI g. 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
Exclusion criteria: a. Patients with CLI indicated for major amputation during screening b. Atherosclerotic PAD c. Ulcers with exposure of tendon and/bone in the shin region. d. Previous above trans metatarsal amputation in study limb e. Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening f. Patients with gait disturbance for reasons other than CLI g. Diagnosis of diabetes mellitus (type 1 or type 2) h. Patients having left ventricular ejection fraction i. Patients suffering from clinically relevant peripheral neuropathy j. History of stroke or myocardial infarction k. Patients who are contraindicated for MRA l. Patients with DVT in any limb. m. Patients who have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy n. Documented terminal illness or cancer or any concomitant disease process with a life expectancy of o. Patients already enrolled in another investigational drug trial or completed within 3 months or those who have received stem cells in the past p. Patient with known hypersensitivity to the constituents of the stempeucel娉?? dimethyl sulfoxide (DMSO) or human serum albumin (HSA) q. History of severe alcohol or drug abuse within 3 months of screening r. Hb% = 2mg%, serum Total Bilirubin >=2mg% s. Pregnant and lactating women t. Patients tested positive for HIV 1 & 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Relief of the rest pain â?¢Healing of ulcerations or reduction of ulcer area in the target limb Timepoint: 6 months and 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Total walking distance â?¢ Major amputation free survival â?¢ Ankle brachial pressure index (ABPI) â?? measured by Doppler â?¢ Quality of life (QOL) by Kings College VascuQOL questionnaire â?¢ Angiogenesis â?? collateral blood vessels by Magnetic resonance angiogram (MRA)Timepoint: 6 months and 24 months | — |
Countries
India
Contacts
Public ContactJijy Abraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed