Status:
UNKNOWN
Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
Lead Sponsor:
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Patients having respiratory complications/left ventricular ejection fraction \< 25%
- Stroke or myocardial infarction within last 3 months
- Patients who are contraindicated for X-ray angiography
- History of severe alcohol or drug abuse within 3 months of screening
- Pregnant and lactating women.
- Patients tested positive for HIV 1, hepatitis C virus (HCV), hepatitis B virus (HBV)
- Unsigned informed consent
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03239535
Start Date
October 1 2013
End Date
November 1 2018
Last Update
August 4 2017
Active Locations (1)
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1
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow, Russia