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

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: 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

Tracking Information
First Submitted Date February 10, 2015
First Posted Date February 25, 2015
Last Update Posted Date March 30, 2018
Study Start Date February 2015
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 18, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02370823 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 18, 2015)
  • Mean Change in Pain Scale from baseline to 6 weeks [ Time Frame: 6 weeks ]
    Mean Numeric Pain Scale
  • Mean Change in IKDC Scores from baseline to 6 weeks [ Time Frame: 6 weeks ]
    Mean Patient Reported Pain and Function Scale
  • 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
  • Incidence and time to re-injection/re-operation [ Time Frame: 6 weeks ]
    Incidence and time to re-injection/re-operation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
Official Title A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Synovial Fluid an QC bone marrow sample may be retained.
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.
Condition Osteoarthritis, Knee
Intervention Procedure: Regenexx SD
stem cell treatment
Other Name: Bone Marrow Concentrate
Study Groups/Cohorts 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.
Intervention: Procedure: Regenexx SD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Estimated Enrollment
 (submitted: February 18, 2015)
20
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02370823
Other Study ID Numbers RSI2014-LAB01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Regenexx, LLC
Study Sponsor Regenexx, LLC
Collaborators Not Provided
Investigators
Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic
PRS Account Regenexx, LLC
Verification Date March 2018