Health Condition 1: M622- Nontraumatic ischemic infarction of muscle
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
Sponsors
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written, signed, dated and ethics committee approved informed consent obtained from patients before performing any procedures. 2. Patients of either sex of 18 years and above with established clinical diagnosis of critical limb ischemia due to Buergerâ??s disease as per Rutherford classification (Rutherford III-5 or III-6 (gangrene limited to the toes)) (Refer Appendix I) with rest pain and / or ulcers in the affected limb. 3. Patients who are not eligible for or have failed traditional revascularization treatment
Exclusion criteria
Exclusion criteria: Patients with known hypersensitivity to the excipients of the stempeucel® â?? dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Safety, tolerability and EfficacyTimepoint: 1, 6 and 12, 24, 36 and 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactMs Jijy Abraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed