Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia1 site in 1 country40 target enrollmentOctober 1, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Critical Limb Ischemia
Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Enrollment: 40
Locations: 1
Primary Endpoint: Adverse events
Last Updated: 8 years ago

The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem cells for the treatment of critical limb ischemia.

Registry

clinicaltrials.gov

Start Date

October 1, 2013

End Date

November 1, 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Responsible Party

Sponsor

•Males or females in the age group of 18-80 yrs of Caucasian origin.
•Peripheral artery disease (PAD) against the background of atherosclerosis and diabetes mellitus (DM)
•Critical lower limb ischemia (stages 3-4 by Fontaine-Pokrovsky or stages 4-6 by Rutherford)
•Patients with remaining symptoms of critical limb ischemia (CLI) in spite of the performed surgical (endovascular or open) treatment and continuing conservative therapy
•Patients with absent emergency indications to major amputation
•Patients planned for the reconstructive surgery with a questionable remote outcome due to compromised blood outflow
•Ankle Brachial Pressure Index (ABPI) ≤ 0.5 or ankle pressure ≤ 70 mm Hg
•Patients, if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8.5 %)
•On regular medication for hypertension if needed
•Normal liver and renal function (or having clinically insignificant deviations, according to the treating physician's opinion)

•Humid gangrene or acute/chronic infection of lower limb.
•Dry gangrene with extensive foot lesion (\> 1\\2).
•Acute arterial failure.
•Life-threatening conditions and predicted life expectancy of \< 6 months.
•Presence of neoplasm or bone marrow disease
•Signs of active or chronic, including latent, haemorrhage
•Any acute or chronic infectious disease
•Renal failure determined as twofold or higher elevation of serum creatinine as compared to the upper normal limit
•Hepatic failure determined as the bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels elevated by two and more times over the upper normal limits
•Thrombocytopenia (platelet counts \< 50,000 /µl), leukocytopenia (WBC \< 4,000/µl), immunosuppressive therapy

Adverse events

Time Frame: 24 months

Number of adverse events reported

Amputation-free survival

Time Frame: 24 months

Number of survived patients

Limb salvage from major amputation(3, 6, 12, 24 months)
Improvement in perfusion by the ankle-brachial index(Immediate, 3, 6, 12, 24 months)
Improvement in healing trophic disorders(Immediate, 3, 6, 12, 24 months)
Improvement in total walking distance (TWD) using a standard treadmill test(Immediate, 3, 6, 12, 24 months)
Relief of the rest pain(Immediate, 3, 6, 12, 24 months)
Improvement in perfusion by radioisotope scintigraphy(Immediate, 3, 6, 12, 24 months)