Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy

August 1, 2017 updated by: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem cells for the treatment of critical limb ischemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mikhail A Konoplyannikov, PhD
  • Phone Number: +79154027268
  • Email: mkonopl@mail.ru

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • Federal Research Clinical Center of Federal Medical & Biological Agency
        • Contact:
          • Mikhail A Konoplyannikov, PhD
          • Phone Number: +79154027268
          • Email: mkonopl@mail.ru

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mesenchymal stem cells
Mesenchymal stem cells, Intramuscular injection
Biological: Mesenchymal stem cells
Intramuscular injection
Placebo Comparator: Normal saline
Normal saline, Intramuscular injection
Biological: Normal saline
Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 24 months
Number of adverse events reported
24 months
Amputation-free survival
Time Frame: 24 months
Number of survived patients
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Limb salvage from major amputation
Time Frame: 3, 6, 12, 24 months
Number of patients who avoided amputation
3, 6, 12, 24 months
Relief of the rest pain
Time Frame: Immediate, 3, 6, 12, 24 months
Rest pain will be measured using the rest pain scale
Immediate, 3, 6, 12, 24 months
Improvement in healing trophic disorders
Time Frame: Immediate, 3, 6, 12, 24 months
Assessment of the severity of trophic ulcers
Immediate, 3, 6, 12, 24 months
Improvement in perfusion by the ankle-brachial index
Time Frame: Immediate, 3, 6, 12, 24 months
Measurements of the ankle-brachial index
Immediate, 3, 6, 12, 24 months
Improvement in perfusion by radioisotope scintigraphy
Time Frame: Immediate, 3, 6, 12, 24 months
Radioisotope scintigraphy study
Immediate, 3, 6, 12, 24 months
Improvement in total walking distance (TWD) using a standard treadmill test
Time Frame: Immediate, 3, 6, 12, 24 months
Standard treadmill test
Immediate, 3, 6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Vladimir P Baklaushev, MD, PhD, Deputy Director
  • Principal Investigator: Pavel Yu Orekhov, MD, PhD, Vascular surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MSC-CLI/FMBA/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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