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A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment

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ClinicalTrials.gov Identifier: NCT02370823
Recruitment Status : Terminated (Terminated early for poor study design.)
First Posted : February 25, 2015
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

Brief Summary:
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Procedure: Regenexx SD

Detailed Description:

The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx SD treatment (day 0).

Secondary objective is an evaluation of possible direct and/or indirect associations between the measured levels of proteins and/or cellular components of the synovial fluid in the osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary objective will include MRI evidence of cartilage repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.


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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
Study Start Date : February 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort Intervention/treatment
Knee OA Treated with Regenexx SD
20 subjects with unilateral knee osteoarthritis. Collection of synovial fluid from both knees will serve as the experimental condition, i.e. the osteoarthritic knee, and the matched control, i.e. the knee not demonstrating signs of osteoarthritis. Alterations in the concentration of the synovial fluid proteins and cellular components will be evaluated up to 6 weeks post-Regenexx® SD - Same Day Bone Marrow Concentrate Injection treatment.
Procedure: Regenexx SD
stem cell treatment
Other Name: Bone Marrow Concentrate




Primary Outcome Measures :
  1. Median change in protein concentration or percentage of cellular subpopulations [ Time Frame: 6 weeks compared to baseline ]
    A comparison of the patient temporal median change in protein concentration or percentage of cellular subpopulations from pre-injection to 6 weeks post- Regenexx SD treatment.


Secondary Outcome Measures :
  1. Mean Change in Pain Scale from baseline to 6 weeks [ Time Frame: 6 weeks ]
    Mean Numeric Pain Scale

  2. Mean Change in IKDC Scores from baseline to 6 weeks [ Time Frame: 6 weeks ]
    Mean Patient Reported Pain and Function Scale

  3. Incidence and time to resolution of post-operative complications and adverse events [ Time Frame: 6 weeks ]
    Incidence and time to resolution of post-operative complications and adverse events

  4. Incidence and time to re-injection/re-operation [ Time Frame: 6 weeks ]
    Incidence and time to re-injection/re-operation


Biospecimen Retention:   Samples With DNA
Synovial Fluid an QC bone marrow sample may be retained.


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
Sampling Method:   Non-Probability Sample
Study Population
Subjects will have unilateral knee OA as evidenced with physical examination and MRI. Subjects will be recruited from the physician practice and will be males and females age 35-85.
Criteria

Inclusion Criteria:

  1. Voluntary signature of the IRB approved Informed Consent
  2. Unilateral osteoarthritic male or female ages 35-85
  3. Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint
  4. Physical examination consistent with osteoarthritis in one knee joint
  5. Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension)
  6. Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of the affected knee showing osteoarthritis
  7. Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.)
  8. Normal range of motion of the unaffected knee
  9. No sign of pain, swelling, and/or functional disability of the unaffected knee
  10. No history of acute injury in the unaffected knee
  11. Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria:

  1. Knee injections of any type within 6 months prior to the study.
  2. 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)
  3. Quinolone or Statin induced myopathy/tendinopathy
  4. Symptomatic lumbar spine pathology (e.g. radicular pain)
  5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam).
  6. Contraindications for MRI
  7. Tested positive or has been treated for a malignancy in the past five years or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
  8. Condition represents a worker's compensation case
  9. Currently involved in a health-related litigation procedure
  10. Is pregnant
  11. Bleeding disorders
  12. Currently taking anticoagulant or immunosuppressive medication
  13. Allergy or intolerance to study medication
  14. Use of chronic opioid
  15. Documented history of drug abuse within six months of treatment

18) 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): NCT02370823


Locations
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United States, Colorado
Centeno-Schultz Clinic
Broomfield, Colorado, United States, 80021
Sponsors and Collaborators
Regenexx, LLC
Investigators
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Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic

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Responsible Party: Regenexx, LLC
ClinicalTrials.gov Identifier: NCT02370823     History of Changes
Other Study ID Numbers: RSI2014-LAB01
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Regenexx, LLC:
Osteoarthritis
Knee
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases