CTRI/2025/06/088469
Not yet recruiting
Post Marketing Surveillance
An observational, practice based, open label, multicenter, post marketing surveillance study in India to assess safety and efficacy of intramuscular administration of REGENACIP® in patients with Critical Limb Ischemia (CLI) due to Buerger’s disease.
Stempeutics Research Pvt. Ltd1 site in 1 country150 target enrollmentStarted: June 24, 2025Last updated:
Overview
- Phase
- Post Marketing Surveillance
- Status
- Not yet recruiting
- Sponsor
- Stempeutics Research Pvt. Ltd
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Safety Endpoint:
Overview
Brief Summary
This is an observational, open label, multicenter, post marketing surveillance study in India to assess safety and efficacy of intramuscular administration of REGENACIP® in patients with Critical Limb Ischemia (CLI) due to Buerger’s disease.
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
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 Buerger’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
- •Patients with known hypersensitivity to the excipients of the REGENACIP® – dimethylsulfoxide (DMSO) or human serum albumin (HSA).
Outcomes
Primary Outcomes
Safety Endpoint:
Time Frame: 1, 6 and 12 months
- Evaluation of adverse events
Time Frame: 1, 6 and 12 months
- Evaluation of drug related adverse events
Time Frame: 1, 6 and 12 months
- Evaluation of occurence of clinical abnormality at site of injection, calf area, vital signs and physical examinations
Time Frame: 1, 6 and 12 months
Secondary Outcomes
- Efficacy assessment will include:(- Rest pain score (VAS Scale score of 0 to 10) (refer appendix II) & or)
Investigators
Dr Pawan Kumar Gupta
Stempeutics Research Pvt Ltd
Study Sites (1)
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