Critical Limb IschemiaPhase 1/2NCT03239535
Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
A Phase 1/2 study testing Mesenchymal stem cells and Normal saline in people with Critical Limb Ischemia, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Mesenchymal stem cells and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2013to 1 Nov 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow
Mikhail A Konoplyannikov, PhD, +79154027268, mkonopl@mail.ru
About this study
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
- Being tested
- Mesenchymal stem cells, Normal saline
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsBiological
Intramuscular injection
Normal salineBiological
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells | Experimental | Mesenchymal stem cells, Intramuscular injection Receives: Biological: Mesenchymal stem cells |
| Normal saline | Placebo comparator | Normal saline, Intramuscular injection Receives: Biological: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Number of adverse events reported
Measured: 24 months
Amputation-free survival
Number of survived patients
Measured: 24 months
Secondary outcomes (6)
Limb salvage from major amputation
Number of patients who avoided amputation
Measured: 3, 6, 12, 24 months
Relief of the rest pain
Rest pain will be measured using the rest pain scale
Measured: Immediate, 3, 6, 12, 24 months
Improvement in healing trophic disorders
Assessment of the severity of trophic ulcers
Measured: Immediate, 3, 6, 12, 24 months
Improvement in perfusion by the ankle-brachial index
Measurements of the ankle-brachial index
Measured: Immediate, 3, 6, 12, 24 months
Improvement in perfusion by radioisotope scintigraphy
Radioisotope scintigraphy study
Measured: Immediate, 3, 6, 12, 24 months
Improvement in total walking distance (TWD) using a standard treadmill test
Standard treadmill test
Measured: Immediate, 3, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start1 Oct 2013
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vladimir P Baklaushev, MD, PhD, Study director, Deputy DirectorPavel Yu Orekhov, MD, PhD, Principal investigator, Vascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239535
- Sponsor's protocol ID
- MSC-CLI/FMBA/001
- Status last verified
- Aug 2017
- First submitted
- 20 Jul 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Mesenchymal Stem Cells for the Critical Limb Ischemia Therapy
- ClinicalTrials.gov ID
- NCT03239535
- Acronym / sponsor ID
- MSC-CLI/FMBA/001
- Conditions
- Critical Limb Ischemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, RussiaOther government
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Nov 2018 (estimated)
- First posted
- 4 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial aims to study the safety and efficacy of adult allogeneic mesenchymal stem cells for the treatment of critical limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells | Experimental | Biological: Mesenchymal stem cellsMesenchymal stem cells, Intramuscular injection |
| Normal saline | Placebo comparator | Biological: Normal salineNormal saline, Intramuscular injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cellsIntramuscular injection | Biological | Mesenchymal stem cells |
| Normal salineIntramuscular injection | Biological | Normal saline |
Primary outcome
Adverse events
Time frame: 24 months
Number of adverse events reported
Amputation-free survival
Time frame: 24 months
Number of survived patients
6 secondary outcomes
Limb salvage from major amputation
Time frame: 3, 6, 12, 24 months
Relief of the rest pain
Time frame: Immediate, 3, 6, 12, 24 months
Improvement in healing trophic disorders
Time frame: Immediate, 3, 6, 12, 24 months
Improvement in perfusion by the ankle-brachial index
Time frame: Immediate, 3, 6, 12, 24 months
Improvement in perfusion by radioisotope scintigraphy
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir P Baklaushev, MD, PhD study director
Deputy Director
Pavel Yu Orekhov, MD, PhD principal investigator
Vascular Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal stem cells and Normal saline in people with Critical Limb Ischemia, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikhail A Konoplyannikov, PhD (+79154027268, mkonopl@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.