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Knee Joint OsteoarthritisPhase 1/2NCT02219113

Effectiveness and Safety of Autologous ADRC for Treatment of Degenerative Damage of Knee Articular Cartilage

A Phase 1/2 study testing Arthroscopic surgery, Liposuction and ADRC isolation in people with Knee Joint Osteoarthritis, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm study with no control. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Knee Joint Osteoarthritis
What is being tested?
Arthroscopic surgery, Liposuction and ADRC isolation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteRussia
Study dates
Jul 2014to Apr 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pain in the knee joint during more than a half day assessed by VAS (score more than 40 mm)
  • At least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch
  • Patient is able to walk without assistance
  • Patient is familiar with Participant information sheet
  • Patient signed informed consent form
  • Non-inclusion Criteria:
Show all 24Show fewer
  • Medical history of endoprosthetic knee replacement
  • Medical history of lower extremity osteotomy
  • Medical history of knee surgery (including arthroscopy) during preceding 1 year prior to enrollment
  • Medical history of intraarticular injections during preceding 6 months prior to enrollment
  • Secondary osteoarthritis of the knee joint: posttraumatic osteoarthritis (developed after clinically significant injury), intra-articular fractures, clinically significant varus or valgus deformities of lower limbs, septic arthritis, joint's inflammatory disorders, gout, advanced chondrocalcinosis, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary synovial osteochondromatosis, osteonecrosis, hemophilia
  • Patients prescribed for immunosuppressive treatment
  • Medical history of systemic autoimmune and inflammatory diseases
  • 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
  • Patients prescribed for systemic corticosteroids or other medications treatment with proven impact on bone or cartilage tissue metabolism
  • 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

Who cannot join

  • 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:
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • 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

Other trials in Russia

About this study

Official title: Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Degenerative Damage of Knee Articular Cartilage

Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm study with no control. All patients receive cell therapy.

Read the detailed description

Patients with verified diagnosis knee joint osteoarthritis (degenerative damage of knee articular cartilage) will undergo knee arthroscopic debridement. 28 days later patients will 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. Extracted ADRC will be administered one-time intraarticularly.

Being tested
Arthroscopic surgery, Liposuction, ADRC isolation, Intraarticular administration of autologous ADRC
Keywords
Damage of articular cartilage, Cartilage degeneration, Intraarticular injection, ADRC, Adipose-derived regenerative cells, Adipose tissue, Stem cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthroscopic surgeryProcedure or surgery

  • LiposuctionProcedure or surgery

  • ADRC isolationDevice

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

  • Intraarticular administration of autologous ADRCOther

Study groups in NCT02219113
Study groupRoleWhat they receive
ADRC injectionExperimentalSubjects 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 knee joint.
Receives: Procedure: Arthroscopic surgery; Procedure: Liposuction; Device: ADRC isolation; Other: Intraarticular administration of autologous ADRC

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)

    Measured: 4 weeks after treatment

Secondary outcomes (4)

  1. 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)

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

  2. Knee pain intensity monitoring

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

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

  3. Changes in knee joint structures

    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)

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

  4. Changes in knee function

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2016
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02219113
Sponsor's protocol ID
RU-CCH-03-02-14
Status last verified
Jul 2017
First submitted
15 Aug 2014
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Arthroscopic surgery, Liposuction and ADRC isolation in people with Knee Joint Osteoarthritis, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of serious adverse events (SAEs) and serious adverse reactions (SARs) (time frame: 4 weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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