Clinical trial NCT02469792: Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture
Official title: Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Anterior Cruciate Ligament Partial Rupture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Anterior Cruciate Ligament Partial Rupture
Keywords: Anterior cruciate ligament
Ligament rupture
Intraarticular injection
ADRC
Adipose-derived regenerative cells
Adipose tissue
Stem cells
Lead sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Sponsor class: OTHER_GOV
Collaborators: name: I.M. Sechenov First Moscow State Medical University
First posted: 2015-06-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.

Detailed description: Patients with verified diagnosis partial rupture of anterior cruciate ligament will undergo liposuction from front abdominal wall under local anesthesia. After that autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from harvested adipose tissue. Same day patients will undergo knee arthroscopic surgery followed by one-time intraarticular freshly isolated ADRC administration (directly into anterior cruciate ligament close to the rupture).

Eligibility criteria: Inclusion Criteria:

* Patient suffers from partial rupture of anterior cruciate ligament (confirmed by MRI or knee arthroscopic surgery)
* Clinically significant knee instability (positive anterior drawer test, pivot shift test, and Lachman test)
* Patient is familiar with Participant information sheet
* Patient signed informed consent form

Non-inclusion Criteria:

* Knee osteoarthritis grade III and grade IV
* Medical history of autoimmune diseases
* Patients prescribed for immunosuppressive treatment
* Contraindications to the general or local anesthesia or medical history of allergic reactions to anesthetics
* Subcompensated or decompensated forms of chronic diseases of internal organs
* Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology
* Medical history of venous thromboembolism or estimated high risk of venous thromboembolism
* Clinically significant abnormalities in results of laboratory tests
* Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and 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.
* Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
* Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration
* Medical history of heterotopic ossifications
* Patients prescribed for glycoprotein inhibitors treatment

Exclusion Criteria:

* Patient's refusal from the further participation in trial
* Patient's refusal from compliance with the requirements of contraception during the participation in research
* Chronic kidney disease IV - V stages (creatinine clearance \< 30 mL/min estimated by Cockroft-Gault formula)
* Confirmed syphilis, HIV, hepatitis B or C infections

Dropout Criteria:

* Complete anterior cruciate ligament rupture confirmed by knee arthroscopic surgery
* Pregnancy

Primary outcomes:
measure: Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: Quality of life monitoring
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Knee pain intensity monitoring
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Changes in knee joint structures
timeFrame: Follow up to completion (up to 24 weeks after treatment)
measure: Changes in knee function
timeFrame: Follow up to completion (up to 24 weeks after treatment)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Sergey V Ivannikov, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
name: Ilya I Eremin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: