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

Primary Purpose

Anterior Cruciate Ligament Partial Rupture

Status

Unknown status

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

Liposuction

ADRC isolation

Arthroscopic surgery

Intraarticular administration of autologous ADRC

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Partial Rupture focused on measuring Anterior cruciate ligament, Ligament rupture, Intraarticular injection, ADRC, Adipose-derived regenerative cells, Adipose tissue, Stem cells

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADRC injection

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life monitoring

Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS)

Knee pain intensity monitoring

Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm)

Changes in knee joint structures

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

Changes in knee function

Changes in knee function assessed by questionnaire: Knee Society Score (KSS)

Full Information

NCT ID

NCT02469792

First Posted

June 9, 2015

Last Updated

July 19, 2017

Sponsor

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Collaborators

I.M. Sechenov First Moscow State Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02469792

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (Actual)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Collaborators

I.M. Sechenov First Moscow State Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Partial Rupture

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ADRC injection

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Liposuction

Intervention Type

Device

Intervention Name(s)

ADRC isolation

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Arthroscopic surgery

Intervention Type

Other

Intervention Name(s)

Intraarticular administration of autologous ADRC

Primary Outcome Measure Information:

Title

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

Time Frame

2 weeks after treatment

Secondary Outcome Measure Information:

Title

Quality of life monitoring

Description

Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS)

Time Frame

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

Title

Knee pain intensity monitoring

Description

Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm)

Time Frame

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

Title

Changes in knee joint structures

Description

Time Frame

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

Title

Changes in knee function

Description

Changes in knee function assessed by questionnaire: Knee Society Score (KSS)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sergey V Ivannikov, Professor

Organizational Affiliation

I.M. Sechenov First Moscow State Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ilya I Eremin, MD, PhD

Organizational 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

Official's Role

Principal Investigator

Facility Information:

Facility Name

City

Moscow

ZIP/Postal Code

121359

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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