Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADRC injection | Procedure | 10 mL of autologous ADRC suspension will be injected intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of ankle-brachial index | Influence of intervention on ankle-brachial index. | 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. |
Not provided
Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Liposuction | Procedure |
|
| 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. | 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. | 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. | 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). | Follow up to completion (24 weeks after intervention) |
| Quality of life monitoring - 2 | Quality of life estimated by validated questionnaire:Peripheral Artery Questionnaire. | Follow up to completion (24 weeks after intervention) |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D001162 | Arteriosclerosis Obliterans |
| D058729 | Peripheral Arterial Disease |
| D013919 | Thromboangiitis Obliterans |
| D003925 | Diabetic Angiopathies |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D014657 | Vasculitis |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
Not provided
Not provided