Regenexx™ SD Versus Exercise Therapy for ACL Tears

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

Tracking Information

• First Submitted Date: May 7, 2013
• First Posted Date: May 9, 2013
• Last Update Posted Date: July 8, 2022
• Study Start Date: May 2013
• Actual Primary Completion Date: May 22, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Regenexx™ SD Versus Exercise Therapy for ACL Tears
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Anterior Cruciate Ligament Tear

Intervention

• Procedure: Regenexx SD
  stem cell treatment
• Other: Exercise Therapy
  exercise therapy control

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2013): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 8, 2022
• Actual Primary Completion Date: May 22, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 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

Administrative Information

• NCT Number: NCT01850758
• Other Study ID Numbers: RSI2013-RCT01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Regenexx, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Regenexx, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christopher Centeno, MD; Centeno-Schultz Clinic

• PRS Account: Regenexx, LLC
• Verification Date: July 2022