Critical Limb Ischemia
Conditions
Keywords
mesenchymal stem cells, critical limb ischemia
Brief summary
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
Interventions
DRUGmesenchymal stem cells
Intramuscular injection
DRUGPlasmalyte A
Intramuscular injection
Sponsors
Stempeutics Research Pvt Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin. * Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients) * Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot * Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications * Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits * Normal liver and renal function * On regular medication for hypertension if any
Exclusion criteria
* Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition * CLI patient requiring amputation proximal to trans-metatarsal level * Patients with gait disturbance for reasons other than CLI. * Type I diabetes * Patients having respiratory complications/left ventricular ejection fraction \< 25%f) Stroke or myocardial infarction within last 3 months * Patients who are contraindicated for MRA * 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 * Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year * Patients already enrolled in another investigational drug trial or completed within 3 months. * History of severe alcohol or drug abuse within 3 months of screening. * Hb% \< 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c \> 8% * Women with child bearing potential, pregnant and lactating women. * Patients tested positive for HIV 1, HCV, HBV,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AE and symptomatic relief | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Increase in transcutaneous partial oxygen pressure (TcPO2) and Ankle brachial pressure index (ABPI) - measured by Doppler | 6 months |
Countries
India
Outcome results
None listed