Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture

NCT02469792 | Unknown Phase 1

• 1 other identifier: RU-CCH-03-01-14
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Partial Rupture

Keywords

Anterior cruciate ligament; Ligament rupture; Intraarticular injection; ADRC; Adipose-derived regenerative cells; Adipose tissue; Stem cells

Outcome Measures

Primary Outcomes (1)

• Number of serious adverse events (SAEs) and serious adverse reactions (SARs)

  2 weeks after treatment

Secondary Outcomes (4)

• Quality of life monitoring

  Follow up to completion (up to 24 weeks after treatment)

• Knee pain intensity monitoring

  Follow up to completion (up to 24 weeks after treatment)

• Changes in knee joint structures

  Follow up to completion (up to 24 weeks after treatment)

• Changes in knee function

  Follow up to completion (up to 24 weeks after treatment)

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 ADRC isolation autologous cells suspension will be injected intraarticularly into anterior cruciated ligament.

Procedure: Liposuction; Device: ADRC isolation; Procedure: Arthroscopic surgery; Other: Intraarticular administration of autologous ADRC

Interventions

Liposuction PROCEDURE

ADRC injection

ADRC isolation DEVICE

ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol

ADRC injection

Arthroscopic surgery PROCEDURE

ADRC injection

Intraarticular administration of autologous ADRC OTHER

ADRC injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation: lead
• I.M. Sechenov First Moscow State Medical University: collaborator

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; Center for Biomedical Technologies

Moscow, 121359, Russia

Location

MeSH Terms

Interventions

Lipectomy; Arthroscopy

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Orthopedic Procedures

Study Officials

• Sergey V Ivannikov, Professor

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

• Ilya I Eremin, MD, PhD

  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

  PRINCIPAL INVESTIGATOR

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: June 9, 2015
• First Posted: June 11, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

RU (1)