Regenexx™ SD Versus Exercise Therapy for ACL Tears

NCT01850758 | Completed

• 1 other identifier: RSI2013-RCT01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Tear

Keywords

ACL; Anterior Cruciate Ligament; ACL Tear; Anterior Cruciate Ligament Tear; Partial ACL Tear

Outcome Measures

Primary Outcomes (1)

• IKDC Subjective Knee Evaluation Score Change from Baseline

  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.

  Change from Baseline to 3 months

Secondary Outcomes (6)

• Mean Pain Scales

  3, 6, 12 and 24 months

• Magnetic Resonance Evaluation of ligament repair

  6 months

• Mean IKDC Subjective Knee Evaluation Scores

  6, 12 and 24 months

• Incidence of complications and adverse events

  24 months

• Incidence of re-injection and surgical revision

  24 months

Study Arms (2)

Regenexx SD

ACTIVE COMPARATOR

Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament.

Procedure: Regenexx SD

Exercise Therapy

ACTIVE COMPARATOR

Subjects will be instructed in a set of appropriate knee strengthening exercises and given an instructional hand-out to take home.

Other: Exercise Therapy

Interventions

Regenexx SD PROCEDURE

stem cell treatment

Regenexx SD

Exercise Therapy OTHER

exercise therapy control

Exercise Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regenexx, LLC: lead

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

Related Publications (1)

• Centeno CJ, Berger DR, Pitts J, Markle J, Pelle AJ, Murphy M, Dodson E. Non-surgical treatment of anterior cruciate ligament tears with percutaneous bone marrow concentrate and platelet products versus exercise therapy: a randomized-controlled, crossover trial with 2-year follow-up. BMC Musculoskelet Disord. 2025 Sep 30;26(1):882. doi: 10.1186/s12891-025-09153-2.

  PMID: 41029301 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Christopher Centeno, MD

  Centeno-Schultz Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 9, 2013
• Study Start: May 1, 2013
• Primary Completion: May 22, 2020
• Study Completion: March 8, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)