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 Stromal Cells.
Stempeucel® will be injected at a dose of 2 million cells/kg bod
Sponsors
Stempeutics Research Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females with non-child bearing potential in the age group of 18-70 years of Indian origin. 2. Established CLI, clinically and hemodynamically confirmed as per III-5, or III-6; 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). 3. Patients having Infra-inguinal arterial occlusive disease (as evidenced by MRA) with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients) 4. Patients should have at least one ulcer (target ulcer): area between 0.5 to 10 cm square (both inclusive) 5. Ankle Brachial Pressure Index (ABPI) less than or equal to 0.6 6. Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c less than or equal to 8 percentage) without complications 7. Normal liver and renal function 8. On regular medication for hypertension if any 9. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent including audio â?? video consent, abide by the study requirements, and agree to return for required follow-up visits
Exclusion criteria
Exclusion criteria: 1. Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure 2. Buergerâ??s Disease as diagnosed by Shionoya criteria 3. Patients with rest pain VAS score less than 3 on rest pain scale of 0 â?? 10 (0 is no pain; 10 is maximum pain) 4. Ulcers with exposure of tendon and/bone in the shin region. 5. Severe, active infection of the involved extremity, including osteomyelitis, fasciitis, or severe/purulent cellulitis. 6. CLI patient requiring amputation proximal to trans-metatarsal level 7. Patients with gait disturbance for reasons other than CLI. 8. Type I diabetes 9. Patients having respiratory complications/left ventricular ejection fraction less than 35% 10. Stroke or myocardial infarction within last 3 months 11. Patients with deep vein thrombosis in any limb 12. Patients who are contraindicated for MRA 13. 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 14. Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year 15. Patients already enrolled in another investigational drug trial or completed within 3 months. 16. Patients who have participated in any stem cell trial / therapy / gene therapy any time in the past 17. History of severe alcohol or drug abuse within 3 months of screening. 18. Hb percentage less than 10 gm percentage for males, Hb percentage less than 9 gm percentage for females, serum creatinine greater than or equal to 2 mg percentage, serum Total Bilirubin greater than or equal to 2 mg percentage 19. Women with child bearing potential, pregnant and lactating women. 20. Patient with known hypersensitivity to the constituents of the IMPâ?? DMSO 21. Patients tested positive for HIV (1 or 2), HCV, HBV, CMV, TPHA 22. Subject is an employee or relative of any member of the Investigational site or the Sponsor. 23. Refusal or inability to give informed consent including audio-video consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy of stempeucel®Timepoint: 1,3,6,12 months after IMP administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the safety of stempeucel®Timepoint: Day 7, 1,3,6,12 months after IMP administration | — |
Countries
India
Contacts
Public ContactMs Jijy Abraham
Stempeutics Research Pvt. Ltd.
Outcome results
None listed