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Knee OsteoarthritisPhase 2NCT02827851

Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy

A Phase 2 study testing Liposuction, SVF isolation and Intraarticular administration of autologous SVF in people with Knee Osteoarthritis, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 4 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly 4 weeks after arthroscopic debridement. All patients will receive cell therapy.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 Osteoarthritis
What is being tested?
Liposuction, SVF isolation and Intraarticular administration of autologous SVF
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesRussia
Study dates
May 2016to Nov 2018
Phase
Phase 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 Visual Analog Pain Scale (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 liposuction
  • 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 Cockcroft-Gault formula)
  • Confirmed syphilis, HIV, hepatitis B or C infections
  • Dropout Criteria:
  • Pregnancy

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

  • Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation

    Moscow, 121359

  • Orenburg City Clinical Hospital #4

    Orenburg, 460000

  • Orenburg Regional Clinical Donor Blood Center

    Orenburg, 460018

  • Orenburg Regional Clinical Hospital

    Orenburg, 460018

Other trials in Russia

About this study

Official title: Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal Vascular Fraction of Cells for Treatment of Knee Articular Cartilage Dystrophy

Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly 4 weeks after arthroscopic debridement. All patients will receive cell therapy.This is a single arm study with no control.

Read the detailed description

Patients undergone arthroscopic debridement for knee osteoarthritis will be subjected to abdominal liposuction under local anaesthesia. Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution. Isolated SVF will be administered in a single dose into anterior part of knee joint cavity 28 days after arthroscopy.

Being tested
Liposuction, SVF isolation, Intraarticular administration of autologous SVF
Keywords
Damage of articular cartilage, Cartilage degeneration, Intraarticular injection, SVF, Stromal vascular fraction, Adipose-derived regenerative cells (ADRC), Adipose tissue, Stem cells
Medical subject headings
Osteoarthritis, Knee

What participants receive

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

  • LiposuctionProcedure or surgery

  • SVF isolationOther

    SVF will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution.

  • Intraarticular administration of autologous SVFOther

Study groups in NCT02827851
Study groupRoleWhat they receive
SVF injectionExperimentalSubjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate stromal vascular fraction of cells (SVF). After SVF isolation autologous cells suspension will be injected intraarticularly into knee joint.
Receives: Procedure: Liposuction; Other: SVF isolation; Other: Intraarticular administration of autologous SVF

What is being measured

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

  1. SAEs monitoring

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

    Measured: 4 weeks after treatment

  2. SARs monitoring

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

    Measured: 4 weeks after treatment

Secondary outcomes (7)

  1. Quality of life monitoring-1

    Quality of life estimated by validated questionnaire - the Short Form (36) Health Survey (SF-36)

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

  2. Quality of life monitoring-2

    Quality of life estimated by validated questionnaire - Knee Injury and Osteoarthritis Outcome Score (KOOS)

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

  3. Knee pain intensity monitoring

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

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

  4. Changes in knee joint structure-1

    Changes in knee joint structure assessed by 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)

  5. Changes in knee joint structure-2

    Changes in knee joint structure assessed by X-ray (joint space width, bone contour, presence of osteophytes and sclerosis)

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

  6. Changes in knee joint structure-3

    Changes in knee joint structure assessed by MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments)

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

  7. 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 posted11 Jul 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionMay 2018 (estimated)
  4. Study completionNov 2018 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02827851
Sponsor's protocol ID
RU-ССН-03-01-16
Status last verified
Jul 2017
First submitted
24 Jun 2016
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Liposuction, SVF isolation and Intraarticular administration of autologous SVF in people with Knee Osteoarthritis, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 4 sites 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: status not confirmed, 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 4 sites 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 phase mean?

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?

Results are not available in the source record.

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?

SAEs monitoring (time frame: 4 weeks after treatment). The study lists 2 primary outcomes in all. 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 NCT02827851.

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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