Effectiveness & Safety of Adipose-Derived Regenerative Cells for

Status Enrolling by invitation

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.

Clinical Trial 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

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02864654
Study type	Interventional
Source	Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati
Contact
Status	Enrolling by invitation
Phase	Phase 1/Phase 2
Start date	July 2016
Completion date	July 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06032065` - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)	Phase 3
Active, not recruiting	`NCT03987061` - MOTIV Bioresorbable Scaffold in BTK Artery Disease	N/A
Recruiting	`NCT03506633` - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients	N/A
Active, not recruiting	`NCT03506646` - Dietary Nitrate Supplementation and Thermoregulation	N/A
Active, not recruiting	`NCT04677725` - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting	`NCT05961943` - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients	N/A
Recruiting	`NCT06047002` - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed	`NCT03185052` - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach	N/A
Recruiting	`NCT05992896` - A Study of Loco-Regional Liposomal Bupivacaine Injection	Phase 4
Completed	`NCT04635501` - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial	N/A
Recruiting	`NCT04584632` - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery	N/A
Withdrawn	`NCT03994185` - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease	N/A
Withdrawn	`NCT03538392` - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting	`NCT02915796` - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty	Phase 1
Active, not recruiting	`NCT02900924` - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed	`NCT02901847` - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.	N/A
Not yet recruiting	`NCT02455726` - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease	N/A
Withdrawn	`NCT02126540` - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries	N/A
Not yet recruiting	`NCT02387450` - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication	Phase 2/Phase 3
Completed	`NCT02384980` - Saving Life and Limb: FES for the Elderly With PAD	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms