Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy

NCT03239535 | Unknown Phase 1

• 1 other identifier: MSC-CLI/FMBA/001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Number of adverse events reported

  24 months

• Amputation-free survival

  Number of survived patients

  24 months

Secondary Outcomes (6)

• Limb salvage from major amputation

  3, 6, 12, 24 months

• Relief of the rest pain

  Immediate, 3, 6, 12, 24 months

• Improvement in healing trophic disorders

  Immediate, 3, 6, 12, 24 months

• Improvement in perfusion by the ankle-brachial index

  Immediate, 3, 6, 12, 24 months

• Improvement in perfusion by radioisotope scintigraphy

  Immediate, 3, 6, 12, 24 months

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

Mesenchymal stem cells, Intramuscular injection

Biological: Mesenchymal stem cells

Normal saline

PLACEBO COMPARATOR

Normal saline, Intramuscular injection

Biological: Normal saline

Interventions

Mesenchymal stem cells BIOLOGICAL

Intramuscular injection

Mesenchymal stem cells

Normal saline BIOLOGICAL

Intramuscular injection

Normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• Pronounced neurological deficit
• Patients with gait disturbance for reasons other than CLI
• Patients not suitable for cell therapy, by the treating physician's opinion
• CLI patients requiring amputation at the proximal to the trans-metatarsal level
• Patients with Type I diabetes

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: lead

Study Sites (1)

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Vladimir P Baklaushev, MD, PhD

  Deputy Director

  STUDY DIRECTOR

• Pavel Yu Orekhov, MD, PhD

  Vascular Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikhail A Konoplyannikov, PhD

CONTACT

+79154027268; mkonopl@mail.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 4, 2017
• Study Start: October 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)