Critical Limb IschemiaPhase 1/2NCT02864654
Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
A Phase 1/2 study testing ADRC injection, ADRC isolation and Liposuction in people with Critical Limb Ischemia and Arteriosclerosis Obliterans, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 1 site in Russia.
Trial summary
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Critical Limb Ischemia, Arteriosclerosis Obliterans, Peripheral Arterial Disease
- What is being tested?
- ADRC injection, ADRC isolation and Liposuction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2016to Jul 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with critical lower limb ischemia, with resting pain wich can't be adequately managed by opioid analgetics and/or foot ulcers or necrosis, with II-4, III-5 и IV-6 stages of chronic arterial failure according to Rutherford's classification
- Ankle-brachial index less than 0.4 and/or ТСрО2 less than 30 mm Hg
- Patients with lower limbs' arteries lesions revealed by angiography uneffectiveness or impossibility of limb's revascularisation or patient's refusal of the procedure
- Patient is familiar with Participant information sheet
- Patient signed informed consent form
- Non-inclusion Criteria:
Show all 15Show fewer
- Contraindications for local anesthesia or history of allergy for local anesthetics
- Systemic glucocorticoid and/or immunosuppressant therapy
- Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.)
- Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
- Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy
- Clinically significant abnormalities in results of laboratory tests
- Patient received anticoagulants at least 12 hours prior the liposuction
- Medical history of heterotopic ossifications
- Patients prescribed for glycoprotein inhibitors treatment
Who cannot join
- Patient's refusal from the further participation in trial
- Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
- Confirmed syphilis, HIV, hepatitis B or C infections
- Dropout Criteria:
- Indications for the amputation of the limb
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Moscow, 121359
About this study
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control.
Read the detailed description
Fat tissue obtainment:
Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.
ADRC isolation:
Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10.5 ml of normal saline. Obtained ADRC divided into 2 portions. First portion (0.5 mL) used for counting, viability and sterility assessment. The second portion (10 ml) placed into sterile syringe for injection.
Autologous ADRC administration
10 mL of autologous ADRC suspension will be injected intramuscularly, close to the site of muscle injury. 10 to 20 injections (0.5 to 1.0 mL each) will be performed so as to infiltrate the injured muscle.
- Conditions
- Critical Limb Ischemia, Arteriosclerosis Obliterans, Peripheral Arterial Disease, Thromboangiitis Obliterans, Diabetic Angiopathies
- Being tested
- ADRC injection, ADRC isolation, Liposuction
- Keywords
- Critical lower limb ischemia, Atherosclerosis obliterans, Diabetic angiopathies, Thromboangiitis obliterans, Ischemic ulcers, Peripheral arterial disease, Indirect revascularisation, Intramuscular injection, Ankle-brachial index, Transcutaneous oxygen tension, Stromal vascular fraction (SVF), Adipose-derived regenerative cells (ADRC), Adipose tissue, Stem cells
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Arteriosclerosis Obliterans, Peripheral Arterial Disease, Thromboangiitis Obliterans, Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRC injectionProcedure or surgery
10 mL of autologous ADRC suspension will be injected intramuscularly
ADRC isolationOther
ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10 ml of normal saline.
LiposuctionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ADRC injection | Experimental | Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate Adipose-derived regenerative cells (ADRC). After isolation 10 mL of autologous ADRC suspension will be injected intramuscularly, close to the site of muscle injury. 10 to 20 injections will be performed so as to infiltrate the injured muscle Receives: Procedure: ADRC injection; Other: ADRC isolation; Procedure: Liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events
Frequency, type and severity of serious adverse events (SAE)
Measured: 4 weeks after injection of ADRC suspension
Serious adverse reactions
Frequency, type and severity of serious adverse reactions (SAR)
Measured: 4 weeks after injection of ADRC suspension
Secondary outcomes (7)
Changes of ankle-brachial index
Influence of intervention on ankle-brachial index.
Measured: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 1
Influence of intervention on blood flow velocity assessed by arterial duplex scanning.
Measured: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 2
Influence of intervention on pulsatility index assessed by arterial duplex scanning.
Measured: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 3
Influence of intervention on resistance index assessed by arterial duplex scanning.
Measured: Follow up to completion (24 weeks after intervention)
Metabolic state of targeted tissues measurements
Changes of transcutaneous oxygen tension (ТсРО2) in injured limb assessed by transcutaneous oximetry.
Measured: Follow up to completion (24 weeks after intervention)
Quality of life monitoring - 1
Quality of life estimated by validated questionnaire: the Short Form (SF-36).
Measured: Follow up to completion (24 weeks after intervention)
Quality of life monitoring - 2
Quality of life estimated by validated questionnaire:Peripheral Artery Questionnaire.
Measured: Follow up to completion (24 weeks after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2017 (estimated)
- Study completionJul 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrey A Kalinin, MD, PhD, Principal investigator, Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian FederationAndrey A Pulin, MD, PhD, Principal investigator, Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian FederationEvgeny R Lysenko, MD, PhD, Prof, Study director, FSBI Federal Clinial Center of Advanced medical Technologies FMBA of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864654
- Sponsor's protocol ID
- RU-CCH-07-01-16
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
- ClinicalTrials.gov ID
- NCT02864654
- Acronym / sponsor ID
- RU-CCH-07-01-16
- Conditions
- Critical Limb Ischemia, Arteriosclerosis Obliterans, Peripheral Arterial Disease, Thromboangiitis Obliterans, Diabetic Angiopathies
- Keywords
- Critical lower limb ischemia, Atherosclerosis obliterans, Diabetic angiopathies, Thromboangiitis obliterans, Ischemic ulcers, Peripheral arterial disease, Indirect revascularisation, Intramuscular injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian FederationOther government
- Study start
- Jul 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 12 Aug 2016 (estimated)
- 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.
Adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion. 10 mL of autologous ADRC suspension injected intramuscularly, close to the site of muscle injury. All patients will receive cell therapy. This is a single arm study with no control.
Detailed description
Fat tissue obtainment:
Subjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.
ADRC isolation:
Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10.5 ml of normal saline. Obtained ADRC divided into 2 portions. First portion (0.5 mL) used for counting, viability and sterility assessment. The second portion (10 ml) placed into sterile syringe for injection.
Autologous ADRC administration
10 mL of autologous ADRC suspension will be injected intramuscularly, close to the site of muscle injury. 10 to 20 injections (0.5 to 1.0 mL each) will be performed so as to infiltrate the injured muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADRC injection | Experimental | Procedure: ADRC injection, Other: ADRC isolation, Procedure: LiposuctionSubjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate Adipose-derived regenerative cells (ADRC). After isolation 10 mL of autologous ADRC suspension will be injected intramuscularly, close to the site of muscle injury. 10 to 20 injections will be performed so as to infiltrate the injured muscle |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with critical lower limb ischemia, with resting pain wich can't be adequately managed by opioid analgetics and/or foot ulcers or necrosis, with II-4, III-5 и IV-6 stages of chronic arterial failure according to Rutherford's classification
- Ankle-brachial index less than 0.4 and/or ТСрО2 less than 30 mm Hg
- Patients with lower limbs' arteries lesions revealed by angiography uneffectiveness or impossibility of limb's revascularisation or patient's refusal of the procedure
- Patient is familiar with Participant information sheet
- Patient signed informed consent form
Key exclusion criteria (5 listed)
- Patient's refusal from the further participation in trial
- Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by Cockcroft-Gault formula)
- Confirmed syphilis, HIV, hepatitis B or C infections
- Indications for the amputation of the limb
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 |
|---|---|---|
| ADRC injection10 mL of autologous ADRC suspension will be injected intramuscularly | Procedure or surgery | ADRC injection |
| ADRC isolationADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10 ml of normal saline. | Other | ADRC injection |
| Liposuction | Procedure or surgery | ADRC injection |
Primary outcome
Serious adverse events
Time frame: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse events (SAE)
Serious adverse reactions
Time frame: 4 weeks after injection of ADRC suspension
Frequency, type and severity of serious adverse reactions (SAR)
7 secondary outcomes
Changes of ankle-brachial index
Time frame: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 1
Time frame: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 2
Time frame: Follow up to completion (24 weeks after intervention)
Changes of hemodynamics in lower extremity - 3
Time frame: Follow up to completion (24 weeks after intervention)
Metabolic state of targeted tissues measurements
Time frame: Follow up to completion (24 weeks after intervention)
Quality of life monitoring - 1
Time frame: Follow up to completion (24 weeks after intervention)
Quality of life monitoring - 2
Time frame: Follow up to completion (24 weeks after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Andrey A Kalinin, MD, PhD principal investigator
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Andrey A Pulin, MD, PhD principal investigator
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Evgeny R Lysenko, MD, PhD, Prof study director
FSBI Federal Clinial Center of Advanced medical Technologies FMBA of Russia
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 ADRC injection, ADRC isolation and Liposuction in people with Critical Limb Ischemia and Arteriosclerosis Obliterans, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation 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 15 inclusion and 5 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 12 Aug 2016. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (time frame: 4 weeks after injection of ADRC suspension). 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 12 Aug 2016; AzTrials last refreshed its copy on 7 Nov 2026.