Mesenchymal Stem Cells in Critical Limb Ischemia

Stempeutics

Status and phase

Completed

Phase 2

Phase 1

Conditions

Critical Limb Ischemia

Treatments

Drug: Plasmalyte A

Drug: mesenchymal stem cells

Study type

Interventional

Funder types

Industry

Identifiers

SRPL/CLI/07-08/001

Details and patient eligibility

About

This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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,