A study of stempeucel® in patients with critical limb ischemia due to occlusive inflammatory condition of arteries and veins

Phase 4

• Conditions: Health Condition 1: M622- Nontraumatic ischemic infarction of muscle

• Registration Number: CTRI/2018/02/011839
• Lead Sponsor: Stempeutics Research Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

Patients with known hypersensitivity to the excipients of the stempeucel® â?? dimethyl sulfoxide (DMSO) or human serum albumin (HSA)

Study & Design

• Study Type: PMS
• Study Design: Not specified