Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy

Critical Limb Ischemia Clinical Trial

Official title:

Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03239535
• Other study ID #: MSC-CLI/FMBA/001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 20, 2017
• Last updated: August 1, 2017
• Start date: October 1, 2013
• Est. completion date: November 1, 2018

Study information

• Verified date: August 2017
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: Mikhail A Konoplyannikov, PhD
• Phone: +79154027268
• Email: mkonopl[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Biological:
• Mesenchymal stem cells
Intramuscular injection
• Normal saline
Intramuscular injection

Locations

Country	Name	City	State
Russian Federation	Federal Research Clinical Center of Federal Medical & Biological Agency	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Number of adverse events reported	24 months
Primary	Amputation-free survival	Number of survived patients	24 months
Secondary	Limb salvage from major amputation	Number of patients who avoided amputation	3, 6, 12, 24 months
Secondary	Relief of the rest pain	Rest pain will be measured using the rest pain scale	Immediate, 3, 6, 12, 24 months
Secondary	Improvement in healing trophic disorders	Assessment of the severity of trophic ulcers	Immediate, 3, 6, 12, 24 months
Secondary	Improvement in perfusion by the ankle-brachial index	Measurements of the ankle-brachial index	Immediate, 3, 6, 12, 24 months
Secondary	Improvement in perfusion by radioisotope scintigraphy	Radioisotope scintigraphy study	Immediate, 3, 6, 12, 24 months
Secondary	Improvement in total walking distance (TWD) using a standard treadmill test	Standard treadmill test	Immediate, 3, 6, 12, 24 months