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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02864654
Other study ID # RU-CCH-07-01-16
Secondary ID
Status Enrolling by invitation
Phase Phase 1/Phase 2
First received August 5, 2016
Last updated August 11, 2016
Start date July 2016
Est. completion date July 2018

Study information

Verified date August 2016
Source Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 9
Est. completion date July 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 85 Years
Eligibility 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 ? IV-6 stages of chronic arterial failure according to Rutherford's classification

- Ankle-brachial index less than 0.4 and/or ????2 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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


Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serious adverse events Frequency, type and severity of serious adverse events (SAE) 4 weeks after injection of ADRC suspension Yes
Primary Serious adverse reactions Frequency, type and severity of serious adverse reactions (SAR) 4 weeks after injection of ADRC suspension Yes
Secondary Changes of ankle-brachial index Influence of intervention on ankle-brachial index. Follow up to completion (24 weeks after intervention) No
Secondary Changes of hemodynamics in lower extremity - 1 Influence of intervention on blood flow velocity assessed by arterial duplex scanning. Follow up to completion (24 weeks after intervention) No
Secondary Changes of hemodynamics in lower extremity - 2 Influence of intervention on pulsatility index assessed by arterial duplex scanning. Follow up to completion (24 weeks after intervention) No
Secondary Changes of hemodynamics in lower extremity - 3 Influence of intervention on resistance index assessed by arterial duplex scanning. Follow up to completion (24 weeks after intervention) No
Secondary Metabolic state of targeted tissues measurements Changes of transcutaneous oxygen tension (????2) in injured limb assessed by transcutaneous oximetry. Follow up to completion (24 weeks after intervention) No
Secondary Quality of life monitoring - 1 Quality of life estimated by validated questionnaire: the Short Form (SF-36). Follow up to completion (24 weeks after intervention) No
Secondary Quality of life monitoring - 2 Quality of life estimated by validated questionnaire:Peripheral Artery Questionnaire. Follow up to completion (24 weeks after intervention) No
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