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Trial record 1 of 4 for:    stem cell therapy | Anterior Cruciate Ligament Tear | United States
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Regenexx™ SD Versus Exercise Therapy for ACL Tears

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ClinicalTrials.gov Identifier: NCT01850758
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : July 8, 2022
Sponsor:
Information provided by (Responsible Party):
Regenexx, LLC

Tracking Information
First Submitted Date  ICMJE May 7, 2013
First Posted Date  ICMJE May 9, 2013
Last Update Posted Date July 8, 2022
Study Start Date  ICMJE May 2013
Actual Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
IKDC Subjective Knee Evaluation Score Change from Baseline [ Time Frame: Change from Baseline to 3 months ]
The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in IKDC scores.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Mean Pain Scales [ Time Frame: 3, 6, 12 and 24 months ]
    Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
  • Magnetic Resonance Evaluation of ligament repair [ Time Frame: 6 months ]
    Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months
  • Mean IKDC Subjective Knee Evaluation Scores [ Time Frame: 6, 12 and 24 months ]
    Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.
  • Incidence of complications and adverse events [ Time Frame: 24 months ]
    Incidence and time to resolution of post-operative complications and adverse events between treatment groups.
  • Incidence of re-injection and surgical revision [ Time Frame: 24 months ]
    Incidence of and time to re-injection and surgical revision between treatment groups.
  • Use of pain medications [ Time Frame: 3, 6, 12 and 24 months ]
    Difference between treatment groups in use of pain medications at each follow-up timepoint
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
  • Mean Pain Scales [ Time Frame: 3, 6, 12 and 24 months ]
    Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
  • Magnetic Resonance Evaluation of ligament repair [ Time Frame: 3 months ]
    Comparison between groups of Magnetic Resonance Evaluation of ligament repair at 3 months
  • Mean IKDC Subjective Knee Evaluation Scores [ Time Frame: 6, 12 and 24 months ]
    Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.
  • Incidence of complications and adverse events [ Time Frame: 24 months ]
    Incidence and time to resolution of post-operative complications and adverse events between treatment groups.
  • Incidence of re-injection and surgical revision [ Time Frame: 24 months ]
    Incidence of and time to re-injection and surgical revision between treatment groups.
  • Use of pain medications [ Time Frame: 3, 6, 12 and 24 months ]
    Difference between treatment groups in use of pain medications at each follow-up timepoint
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regenexx™ SD Versus Exercise Therapy for ACL Tears
Official Title  ICMJE A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears
Brief Summary

The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx SD vs. Exercise Therapy treatment of partial and complete, non-retracted knee ACL ligament tears, from baseline to 3 months, with continued evaluation of efficacy and durability up to 24 months.

Secondary objectives include evaluation of MRI evidence of tendon repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

Detailed Description

Prospective, randomized, controlled to include 25 subjects treated with Regenexx SD and 25 subjects treated with exercise therapy alone with the exercise group crossing over to the injection group at 3 months.

Subjects will have a partial or complete, non-retracted ACL ligament tear as evidenced with MRI.

Subjects will be enrolled within 60 days prior to Regenexx-SD injection or initiation of exercise therapy and take part in follow-up visits for two years following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months, 12 months, and 24 months post injection.

The primary endpoint analysis will be conducted once all subjects reach the 3 month endpoint. Subjects will continue to be followed through the 2 year endpoint with data analysis performed at the 1 year and 2 year time points.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anterior Cruciate Ligament Tear
Intervention  ICMJE
  • Procedure: Regenexx SD
    stem cell treatment
  • Other: Exercise Therapy
    exercise therapy control
Study Arms  ICMJE
  • Active Comparator: Regenexx SD
    Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament.
    Intervention: Procedure: Regenexx SD
  • Active Comparator: Exercise Therapy
    Subjects will be instructed in a set of appropriate knee strengthening exercises and given an instructional hand-out to take home.
    Intervention: Other: Exercise Therapy
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 8, 2022
Actual Primary Completion Date May 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pain, swelling, or functional disability in the affected knee with activity, having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months or unable to return to normal day to day activities by 6 weeks
  • Physical examination consistent with lax ACL ligament (Anterior Drawer Test)
  • Abnormal Telos Arthrometer measurement
  • Positive diagnostic MR imaging of the affected knee with at least 1/3 of the ACL ligament at any area along its length having high signal on MRI PDFS/Fat Sat images.
  • Full range of motion of the affected knee (other than restriction clearly due to effusion)
  • Normal range of motion of the non-treated knee
  • Is independent, ambulatory, and can comply with all post-operative evaluations and visits

Exclusion Criteria:

  • A massive ACL tear or one that includes more than 2/3'rds of the ligament that's retracted.
  • Previous surgery to the affected ACL (i.e. previous ACL replacement with an autograft or allograft)
  • Prior ACL prolotherapy, PRP, corticosteroid injection or other injection therapy within the past three months,
  • Concomitant meniscus tear or cartilage injury that occurred at the same time as the as the ACL tear and which is considered a pain generator by the treating physician at the time intake into the study (i.e. a meniscus tear or cartilage lesion associated with an active BML).
  • Concomitant PCL or LCL tears
  • 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
  • Kellgren-Lawrence grade 2 or greater knee osteoarthritis
  • Significant knee extension lag compared to the opposite knee
  • Symptomatic lumbar spine pathology (e.g. radicular pain)
  • Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
  • Contraindications for MRI
  • Tested positive or has been treated for a malignancy in the past 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
  • 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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01850758
Other Study ID Numbers  ICMJE RSI2013-RCT01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Regenexx, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regenexx, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Centeno, MD Centeno-Schultz Clinic
PRS Account Regenexx, LLC
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP