Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment (KneeOA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02848027
Recruitment Status : Enrolling by invitation
First Posted : July 28, 2016
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

Brief Summary:
Single-center, lab blinded to include up to 400 subjects with knee osteoarthritis. Collection of synovial fluid from diseased knee before and after Regenexx®SD treatment will serve as the experimental condition, i.e. the osteoarthritic knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Biological: Regenexx SD® procedure Phase 3

Detailed Description:

Single-center, laboratory blinded to include up to 400 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s.Initial study procedures include baseline evaluation of medical history, knee history, knee examination, medication use, MRI, and subject-reported outcomes.

Subjects will be enrolled within the 120 days prior to Regenexx® SD injection. A preoperative visit will occur at the time of enrollment. Collection of synovial fluid from the OA knee/s will serve as the experimental condition, i.e. the osteoarthritic knee.Each osteoarthritic subject will undergo withdrawal of knee joint synovial fluid for each knee being treated (0.3-0.5 ml) which will be analyzed by the research laboratory via multiplexed enzyme linked immunosorbent assay (ELISA) and dimethylmethylene blue assay (DMMB) at pre-injection (2-8 days before Regenexx® SD treatment) and post-injection (2-8 days after Regenexx® SD). Documentation of osteoarthritic joint characteristics and injection procedure details will be recorded throughout the study.

The unaffected knee joint will undergo no treatment, but bilateral knees may be treated.

Components of the synovial fluid will be correlated to post-treatment clinical outcomes, which include patient-reported questionnaires as well as assessment of post-injection complications, adverse events, re-injections and surgical interventions. Patient-reported clinical outcomes are comprised of the IKDC Subjective Knee Evaluation, the Lower Extremity Function Scale, Numeric Pain Scale and a Patient Reported Percent Improvement form.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
Study Start Date : September 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Regenexx-SD procedure
Measure components of knee synovial fluid collected 2-4 days before and after Regenexx SD procedure
Biological: Regenexx SD® procedure
Correlate patient outcomes 6 months after receiving the Regenexx SD procedure with measurements of synovial fluid collected before and after procedure.




Primary Outcome Measures :
  1. Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure. [ Time Frame: 6 months after Regenexx-SD procedure ]
    Synovial fluid components include cytokine, matrix metalloproteinase levels, and catabolic cartilage breakdown products. These components of synovial fluid will be correlated to the following patient-reported outcomes 6 months after procedure: the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation form.


Secondary Outcome Measures :
  1. Comparison of synovial fluid contents [ Time Frame: fluid taken ~2-4 days before procedure and ~2-4 days after procedure ]
    Comparison of cytokine, matrix metalloproteinase concentration levels and cartilage breakdown product levels from pre-Regenexx SD treatment to post-Regenexx SD treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntary signature of the IRB approved Informed Consent
  2. Unilateral or bilateral osteoarthritic male or female ages 35-85
  3. Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
  4. Physical examination consistent with osteoarthritis in one knee joint
  5. Kellgren-Lawrence grade 2 or greater knee osteoarthritis and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc…)
  6. Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria:

  1. Knee injections of any type within 3 months prior to the study.
  2. Knee surgery within 6 months prior to the study.
  3. Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
  4. Quinolone or Statin induced myopathy/tendinopathy
  5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
  6. Contraindications for MRI
  7. Condition represents a worker's compensation case
  8. Currently involved in a health-related litigation procedure
  9. Is pregnant
  10. Bleeding disorders
  11. Currently taking anticoagulant or immunosuppressive medication
  12. Allergy or intolerance to study medication
  13. Use of chronic opioid
  14. Documented history of drug abuse within six months of treatment
  15. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment

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): NCT02848027


Sponsors and Collaborators
Regenexx, LLC
Investigators
Layout table for investigator information
Study Director: Neven Steinmetz, Ph.D. Regenexx, LLC
Principal Investigator: Christopher J Centeno, M.D. Regenexx, LLC

Publications:

Layout table for additonal information
Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT02848027     History of Changes
Other Study ID Numbers: RSI2015-LAB02
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases