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Trial record 3 of 8 for:    Eremin

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

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ClinicalTrials.gov Identifier: NCT02469792
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2015
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
I.M. Sechenov First Moscow State Medical University
Information provided by (Responsible Party):
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Partial Rupture Procedure: Liposuction Device: ADRC isolation Procedure: Arthroscopic surgery Other: Intraarticular administration of autologous ADRC Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Anterior Cruciate Ligament Partial Rupture
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: ADRC injection
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
ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol

Procedure: Arthroscopic surgery
Other: Intraarticular administration of autologous ADRC



Primary Outcome Measures :
  1. Number of serious adverse events (SAEs) and serious adverse reactions (SARs) [ Time Frame: 2 weeks after treatment ]

Secondary Outcome Measures :
  1. Quality of life monitoring [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS)

  2. Knee pain intensity monitoring [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm)

  3. Changes in knee joint structures [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]

    Changes in knee joint structure assessed by:

    1. X-ray (joint space width, bone contour, presence of osteophytes and sclerosis);
    2. MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments);
    3. Ultrasonography (effusion, synovial thickening or hypertrophy, cartilage parameters, vascularity, Baker's cysts, osteophytes, tendon and ligament abnormalities, meniscal changes, bursitis, erosions and panniculitis)

  4. Changes in knee function [ Time Frame: Follow up to completion (up to 24 weeks after treatment) ]
    Changes in knee function assessed by questionnaire: Knee Society Score (KSS)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469792


Locations
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Russian Federation
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, Russian Federation, 121359
Sponsors and Collaborators
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
I.M. Sechenov First Moscow State Medical University
Investigators
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Principal Investigator: 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

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Responsible Party: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
ClinicalTrials.gov Identifier: NCT02469792     History of Changes
Other Study ID Numbers: RU-CCH-03-01-14
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation:
Anterior cruciate ligament
Ligament rupture
Intraarticular injection
ADRC
Adipose-derived regenerative cells
Adipose tissue
Stem cells

Additional relevant MeSH terms:
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Rupture
Wounds and Injuries