Critical Limb Ischemia
Conditions
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.
Interventions
BIOLOGICALMesenchymal stem cells
Intramuscular injection
BIOLOGICALNormal saline
Intramuscular injection
Sponsors
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females in the age group of 18-80 yrs of Caucasian origin. 2. Peripheral artery disease (PAD) against the background of atherosclerosis and diabetes mellitus (DM) 3. Critical lower limb ischemia (stages 3-4 by Fontaine-Pokrovsky or stages 4-6 by Rutherford) 4. Patients with remaining symptoms of critical limb ischemia (CLI) in spite of the performed surgical (endovascular or open) treatment and continuing conservative therapy 5. Patients with absent emergency indications to major amputation 6. Patients planned for the reconstructive surgery with a questionable remote outcome due to compromised blood outflow 7. Ankle Brachial Pressure Index (ABPI) ≤ 0.5 or ankle pressure ≤ 70 mm Hg 8. Patients, if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8.5 %) 9. On regular medication for hypertension if needed 10. Normal liver and renal function (or having clinically insignificant deviations, according to the treating physician's opinion) 11. 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
Exclusion criteria
1. Humid gangrene or acute/chronic infection of lower limb. 2. Dry gangrene with extensive foot lesion (\> 1\\2). 3. Acute arterial failure. 4. Life-threatening conditions and predicted life expectancy of \< 6 months. 5. Presence of neoplasm or bone marrow disease 6. Signs of active or chronic, including latent, haemorrhage 7. Any acute or chronic infectious disease 8. Renal failure determined as twofold or higher elevation of serum creatinine as compared to the upper normal limit 9. 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 10. Thrombocytopenia (platelet counts \< 50,000 /µl), leukocytopenia (WBC \< 4,000/µl), immunosuppressive therapy 11. Pronounced neurological deficit 12. Patients with gait disturbance for reasons other than CLI 13. Patients not suitable for cell therapy, by the treating physician's opinion 14. CLI patients requiring amputation at the proximal to the trans-metatarsal level 15. Patients with Type I diabetes 16. Patients having respiratory complications/left ventricular ejection fraction \< 25% 17. Stroke or myocardial infarction within last 3 months 18. Patients who are contraindicated for X-ray angiography 19. History of severe alcohol or drug abuse within 3 months of screening 20. Pregnant and lactating women. 21. Patients tested positive for HIV 1, hepatitis C virus (HCV), hepatitis B virus (HBV) 22. Unsigned informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 24 months | Number of adverse events reported |
| Amputation-free survival | 24 months | Number of survived patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in healing trophic disorders | Immediate, 3, 6, 12, 24 months | Assessment of the severity of trophic ulcers |
| Improvement in perfusion by the ankle-brachial index | Immediate, 3, 6, 12, 24 months | Measurements of the ankle-brachial index |
| Limb salvage from major amputation | 3, 6, 12, 24 months | Number of patients who avoided amputation |
| Improvement in total walking distance (TWD) using a standard treadmill test | Immediate, 3, 6, 12, 24 months | Standard treadmill test |
| Improvement in perfusion by radioisotope scintigraphy | Immediate, 3, 6, 12, 24 months | Radioisotope scintigraphy study |
| Relief of the rest pain | Immediate, 3, 6, 12, 24 months | Rest pain will be measured using the rest pain scale |
Countries
Russia
Contacts
Primary ContactMikhail A Konoplyannikov, PhD
Outcome results
None listed