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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Regenexx SD® procedure
Sponsored by
Regenexx, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Regenexx-SD procedure

    Arm Description

    Measure components of knee synovial fluid collected 2-4 days before and after Regenexx SD procedure

    Outcomes

    Primary Outcome Measures

    Correlation between components in knee synovial fluid to patient-reported outcomes post-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

    Comparison of synovial fluid contents
    Comparison of cytokine, matrix metalloproteinase concentration levels and cartilage breakdown product levels from pre-Regenexx SD treatment to post-Regenexx SD treatment.

    Full Information

    First Posted
    September 30, 2015
    Last Updated
    July 6, 2022
    Sponsor
    Regenexx, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02848027
    Brief Title
    Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
    Acronym
    KneeOA
    Official Title
    Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    September 8, 2015 (Actual)
    Primary Completion Date
    June 30, 2020 (Actual)
    Study Completion Date
    August 19, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Regenexx, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Regenexx-SD procedure
    Arm Type
    Experimental
    Arm Description
    Measure components of knee synovial fluid collected 2-4 days before and after Regenexx SD procedure
    Intervention Type
    Biological
    Intervention Name(s)
    Regenexx SD® procedure
    Intervention Description
    Correlate patient outcomes 6 months after receiving the Regenexx SD procedure with measurements of synovial fluid collected before and after procedure.
    Primary Outcome Measure Information:
    Title
    Correlation between components in knee synovial fluid to patient-reported outcomes post-procedure.
    Description
    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.
    Time Frame
    6 months after Regenexx-SD procedure
    Secondary Outcome Measure Information:
    Title
    Comparison of synovial fluid contents
    Description
    Comparison of cytokine, matrix metalloproteinase concentration levels and cartilage breakdown product levels from pre-Regenexx SD treatment to post-Regenexx SD treatment.
    Time Frame
    fluid taken ~2-4 days before procedure and ~2-4 days after procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Voluntary signature of the IRB approved Informed Consent Unilateral or bilateral osteoarthritic male or female ages 35-85 Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint Physical examination consistent with osteoarthritis in one knee joint 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…) Is independent, ambulatory, and can comply with all post-operative evaluations and visits Exclusion Criteria: Knee injections of any type within 3 months prior to the study. Knee surgery within 6 months prior to the study. 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) Quinolone or Statin induced myopathy/tendinopathy Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh Contraindications for MRI Condition represents a worker's compensation case Currently involved in a health-related litigation procedure Is pregnant Bleeding disorders Currently taking anticoagulant or immunosuppressive medication Allergy or intolerance to study medication Use of chronic opioid Documented history of drug abuse within six months of treatment Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neven Steinmetz, Ph.D.
    Organizational Affiliation
    Regenexx, LLC
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Christopher J Centeno, M.D.
    Organizational Affiliation
    Regenexx, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    16956842
    Citation
    Bain BJ. Morbidity associated with bone marrow aspiration and trephine biopsy - a review of UK data for 2004. Haematologica. 2006 Sep;91(9):1293-4.
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    Citation
    Centeno CJ, Schultz JR, Cheever M, Freeman M, Faulkner S, Robinson B, Hanson R. Safety and complications reporting update on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2011 Dec;6(4):368-78. doi: 10.2174/157488811797904371.
    Results Reference
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    PubMed Identifier
    19951252
    Citation
    Centeno CJ, Schultz JR, Cheever M, Robinson B, Freeman M, Marasco W. Safety and complications reporting on the re-implantation of culture-expanded mesenchymal stem cells using autologous platelet lysate technique. Curr Stem Cell Res Ther. 2010 Mar;5(1):81-93. doi: 10.2174/157488810790442796.
    Results Reference
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    PubMed Identifier
    20392971
    Citation
    Nejadnik H, Hui JH, Feng Choong EP, Tai BC, Lee EH. Autologous bone marrow-derived mesenchymal stem cells versus autologous chondrocyte implantation: an observational cohort study. Am J Sports Med. 2010 Jun;38(6):1110-6. doi: 10.1177/0363546509359067. Epub 2010 Apr 14.
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    PubMed Identifier
    20603892
    Citation
    Wakitani S, Okabe T, Horibe S, Mitsuoka T, Saito M, Koyama T, Nawata M, Tensho K, Kato H, Uematsu K, Kuroda R, Kurosaka M, Yoshiya S, Hattori K, Ohgushi H. Safety of autologous bone marrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011 Feb;5(2):146-50. doi: 10.1002/term.299.
    Results Reference
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    PubMed Identifier
    16870824
    Citation
    Irrgang JJ, Anderson AF, Boland AL, Harner CD, Neyret P, Richmond JC, Shelbourne KD; International Knee Documentation Committee. Responsiveness of the International Knee Documentation Committee Subjective Knee Form. Am J Sports Med. 2006 Oct;34(10):1567-73. doi: 10.1177/0363546506288855. Epub 2006 Jul 26.
    Results Reference
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    Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx®SD Treatment

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