Health Condition 1: I731- Thromboangiitis obliterans [Buergers disease]
Conditions
Interventions
Intervention1: Regenacip: Single Intramuscular administration
Control Intervention1: NIL: NIL
Sponsors
Stempeutics Research Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Written, signed, dated informed consent obtained from patients. 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 III) with rest pain and / or ulcers in the affected limb. 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 REGENACIP® â?? dimethylsulfoxide (DMSO) or human serum albumin (HSA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoint: - Evaluation of adverse events - Evaluation of drug related adverse events - Evaluation of occurence of clinical abnormality at site of injection, calf area, vital signs and physical examinationsTimepoint: 1, 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy assessment will include: - Rest pain score (VAS Scale score of 0 to 10) (refer appendix II) & or - Ankle brachial pressure index (Ratio of ankle pressure to brachial pressure) & or - Ulcer status (Ulcer Present (Yes/No). If present (healed/Improved/not healed at follow up)Timepoint: Assessment will be performed at 1, 6 and 12 Month | — |
Countries
India
Contacts
Public ContactJijy Abraham
Stempeutics Research Pvt Ltd
Outcome results
None listed