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Correlating the OA Knee Microenvironment to Outcomes After Regenexx-SD Treatment: A Multi-Site Study

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ClinicalTrials.gov Identifier: NCT03898388
Recruitment Status : Enrolling by invitation
First Posted : April 2, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

Brief Summary:
Multi-center study to include up to 600 subjects with knee osteoarthritis in unilateral or bilateral knees treated with Regenexx® SD in the osteoarthritic knee/s. Synovial fluid drawn from patients' knee/s prior to receiving Regenexx-SD treatment will be correlated with their clinical outcomes after treatment.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: Bone Marrow Concentrate treatment Not Applicable

Detailed Description:

Initial study procedures include baseline evaluation of medical history, knee history, knee examination, medication use, MRI, and subject-reported outcomes.

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). 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.

The objective of this study is to correlate the pre- Regenexx-SD treatment levels of pro-inflammatory cytokines, anti-inflammatory cytokines, matrix metalloproteinases, and catabolic articular cartilage breakdown products in the osteoarthritic knee synovial fluid microenvironment with 6 month post-treatment clinical outcomes. This data will be used to establish a predictive a priori testing "model" to determine if a patient is a good candidate for the Regenexx-SD treatment based on their initial osteoarthritic knee synovial fluid microenvironment phenotype. It may also be used to determine if the micro-environment can be altered to improve outcome before receiving Regenexx-SD.

Incidence of post-operative complications, adverse events, re-injections, and surgical intervention and change in pain score will be considered while determining these direct and indirect associations upon completion of the Regenexx-SD treatment.

Components of the synovial fluid will be correlated to post-treatment clinical outcomes, which include several self-reported questionnaires as well as assessment of post-injection complications, adverse events, re-injections and surgical interventions. Patient reported questionnaires include IKDC Subjective Knee Evaluation, Lower Extremity Function Scale, Pain Scales and a Modified Single Assessment Numeric Evaluation (SANE).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 1
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Analysis Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx® SD Treatment: A Multi-Site Study
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Knee Synovial Fluid collection before Regenexx-SD
Measure components of knee synovial fluid 2-4 days before the Regenexx-SD treatment.
Procedure: Bone Marrow Concentrate treatment
Correlate patient outcomes 6 months after receiving the Regenexx SD treatment with measurements of synovial fluid collected before treatment
Other Name: Regenexx®SD Treatment




Primary Outcome Measures :
  1. Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure. [ Time Frame: 6 months after Regenexx-SD treatment ]
    1) Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to IKDC delta scores at 6 months.


Secondary Outcome Measures :
  1. Correlation between components of synovial fluid to 12 month IKDC outcomes [ Time Frame: 12 months ]
    Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to IKDC delta scores at 12 months.

  2. Correlation between components of synovial fluid and 6 month pain score [ Time Frame: 6 months ]
    Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to pain scale deltas at 6 months.

  3. Correlation between components of synovial fluid and 6 month Lower Extremity Function Scale (LEFS). [ Time Frame: 6 months ]
    Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to LEFS deltas at 6 months.

  4. Correlation between components of synovial fluid and 6 month modified Single Assessment Numeric Evaluation (SANE) [ Time Frame: 6 months ]
    Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to SANE scores at 6 months.

  5. Correlation between components of synovial fluid and 12 month pain scores [ Time Frame: 12 months ]
    Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to pain scale deltas at 12 months.

  6. Correlation between components of synovial fluid and 12 month LEFS [ Time Frame: 12 months ]
    Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to LEFS deltas at 12 months.

  7. Correlation between components of synovial fluid and modified SANE [ Time Frame: 12 months ]
    Correlations between cytokine levels, matrix metalloproteinase levels, and catabolic cartilage breakdown products from pre-treatment synovial fluid to modified SANE scores at 12 months.



Information from the National Library of Medicine

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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:

  • 7) Knee injections of any type within 3 months prior to the study. 8) Knee surgery within 6 months prior to the study.

    9) Patient undergoing lavage with treatment

    10) 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) 11) Quinolone or statin-induced myopathy/tendinopathy 12) Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh 13) Contraindications for MRI 14) Condition represents a worker's compensation case 15) Currently involved in a health-related litigation procedure 16) Is pregnant 17) Bleeding disorders 18) Currently taking anticoagulant or immunosuppressive medication 19) Allergy or intolerance to study medication 20) Use of chronic opioid 21) Documented history of drug abuse within six months of treatment 22) 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): NCT03898388


Locations
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United States, California
Health Link Medical Center
Oceanside, California, United States, 92056
United States, Georgia
Interventional Orthopedics of Atlanta
Atlanta, Georgia, United States, 30305
United States, Iowa
Regenexx Des Moines
Des Moines, Iowa, United States, 50321
United States, Missouri
Regenexx Kansas City
Kansas City, Missouri, United States, 64131
United States, Nevada
Regenexx Las Vegas
Las Vegas, Nevada, United States, 89074
Sponsors and Collaborators
Regenexx, LLC
Investigators
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Principal Investigator: Christopher Centeno, MD Regenexx, LLC

Publications:
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Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT03898388     History of Changes
Other Study ID Numbers: RGX2018-LAB01
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases