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Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia

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ClinicalTrials.gov Identifier: NCT02864654
Recruitment Status : Unknown
Verified August 2016 by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation.
Recruitment status was:  Enrolling by invitation
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Arteriosclerosis Obliterans Peripheral Arterial Disease Thromboangiitis Obliterans Diabetic Angiopathies Procedure: ADRC injection Other: ADRC isolation Procedure: Liposuction Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Adipose-Derived Regenerative Cells for the Treatment of Critical Lower Limb Ischemia
Study Start Date : July 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ADRC injection
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
Procedure: ADRC injection
10 mL of autologous ADRC suspension will be injected intramuscularly

Other: ADRC isolation
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.

Procedure: Liposuction



Primary Outcome Measures :
  1. Serious adverse events [ Time Frame: 4 weeks after injection of ADRC suspension ]
    Frequency, type and severity of serious adverse events (SAE)

  2. Serious adverse reactions [ Time Frame: 4 weeks after injection of ADRC suspension ]
    Frequency, type and severity of serious adverse reactions (SAR)


Secondary Outcome Measures :
  1. Changes of ankle-brachial index [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on ankle-brachial index.

  2. Changes of hemodynamics in lower extremity - 1 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on blood flow velocity assessed by arterial duplex scanning.

  3. Changes of hemodynamics in lower extremity - 2 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on pulsatility index assessed by arterial duplex scanning.

  4. Changes of hemodynamics in lower extremity - 3 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Influence of intervention on resistance index assessed by arterial duplex scanning.

  5. Metabolic state of targeted tissues measurements [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Changes of transcutaneous oxygen tension (ТсРО2) in injured limb assessed by transcutaneous oximetry.

  6. Quality of life monitoring - 1 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Quality of life estimated by validated questionnaire: the Short Form (SF-36).

  7. Quality of life monitoring - 2 [ Time Frame: Follow up to completion (24 weeks after intervention) ]
    Quality of life estimated by validated questionnaire:Peripheral Artery Questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864654


Locations
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Russian Federation
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Moscow, Russian Federation, 121359
Sponsors and Collaborators
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Investigators
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Principal Investigator: Andrey A Kalinin, MD, PhD Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Principal Investigator: Andrey A Pulin, MD, PhD Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Study Director: Evgeny R Lysenko, MD, PhD, Prof FSBI Federal Clinial Center of Advanced medical Technologies FMBA of Russia

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Responsible Party: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
ClinicalTrials.gov Identifier: NCT02864654     History of Changes
Other Study ID Numbers: RU-CCH-07-01-16
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation:
Peripheral arterial disease
Adipose-derived regenerative cells (ADRC)
Stem cells
Critical lower limb ischemia
Atherosclerosis obliterans
Diabetic angiopathies
Thromboangiitis obliterans
Ischemic ulcers
Indirect revascularisation
Intramuscular injection
Ankle-brachial index
Transcutaneous oxygen tension
Stromal vascular fraction (SVF)
Adipose tissue

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Endocrine System Diseases
Ischemia
Arteriosclerosis
Arteriosclerosis Obliterans
Diabetic Angiopathies
Thromboangiitis Obliterans
Atherosclerosis
Diabetes Complications
Diabetes Mellitus
Vasculitis