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

NCT02864654 | Unknown Phase 1

• 1 other identifier: RU-CCH-07-01-16
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

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; Ankle-brachial index; Transcutaneous oxygen tension; Stromal vascular fraction (SVF); Adipose-derived regenerative cells (ADRC); Adipose tissue; Stem cells

Outcome Measures

Primary Outcomes (2)

• Serious adverse events

  Frequency, type and severity of serious adverse events (SAE)

  4 weeks after injection of ADRC suspension

• Serious adverse reactions

  Frequency, type and severity of serious adverse reactions (SAR)

  4 weeks after injection of ADRC suspension

Secondary Outcomes (7)

• Changes of ankle-brachial index

  Follow up to completion (24 weeks after intervention)

• Changes of hemodynamics in lower extremity - 1

  Follow up to completion (24 weeks after intervention)

• Changes of hemodynamics in lower extremity - 2

  Follow up to completion (24 weeks after intervention)

• Changes of hemodynamics in lower extremity - 3

  Follow up to completion (24 weeks after intervention)

• Metabolic state of targeted tissues measurements

  Follow up to completion (24 weeks after intervention)

Study Arms (1)

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

Procedure: ADRC injection; Other: ADRC isolation; Procedure: Liposuction

Interventions

ADRC injection PROCEDURE

10 mL of autologous ADRC suspension will be injected intramuscularly

ADRC injection

ADRC isolation OTHER

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.

ADRC injection

Liposuction PROCEDURE

ADRC injection

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation: lead

Study Sites (1)

Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

Moscow, 121359, Russia

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Arteriosclerosis Obliterans; Peripheral Arterial Disease; Thromboangiitis Obliterans; Diabetic Angiopathies

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Vasculitis; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Evgeny R Lysenko, MD, PhD, Prof

  FSBI Federal Clinial Center of Advanced medical Technologies FMBA of Russia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 12, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 12, 2016

Record last verified: 2016-08

Locations

RU (1)