Anterior Cruciate Ligament TearNCT01850758
Regenexx™ SD Versus Exercise Therapy for ACL Tears
A study testing Regenexx SD and Exercise Therapy in people with Anterior Cruciate Ligament Tear, run by Regenexx, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- Regenexx SD and Exercise Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 8 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- Regenexx SD, Exercise Therapy
- Keywords
- ACL, Anterior Cruciate Ligament, ACL Tear, Anterior Cruciate Ligament Tear, Partial ACL Tear
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenexx SDProcedure or surgery
stem cell treatment
Exercise TherapyOther
exercise therapy control
| Study group | Role | What they receive |
|---|---|---|
| Regenexx SD | Active comparator | Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament. Receives: 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. Receives: Other: Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 3 months
Secondary outcomes (6)
Mean Pain Scales
Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint
Measured: 3, 6, 12 and 24 months
Magnetic Resonance Evaluation of ligament repair
Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months
Measured: 6 months
Mean IKDC Subjective Knee Evaluation Scores
Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.
Measured: 6, 12 and 24 months
Incidence of complications and adverse events
Incidence and time to resolution of post-operative complications and adverse events between treatment groups.
Measured: 24 months
Incidence of re-injection and surgical revision
Incidence of and time to re-injection and surgical revision between treatment groups.
Measured: 24 months
Use of pain medications
Difference between treatment groups in use of pain medications at each follow-up timepoint
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startMay 2013
- Primary completion22 May 2020
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850758
- Sponsor's protocol ID
- RSI2013-RCT01
- Status last verified
- Jul 2022
- First submitted
- 7 May 2013
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 41029301
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears
- ClinicalTrials.gov ID
- NCT01850758
- Acronym / sponsor ID
- RSI2013-RCT01
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- ACL, Anterior Cruciate Ligament, ACL Tear, Anterior Cruciate Ligament Tear, Partial ACL Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenexx SD | Active comparator | Procedure: Regenexx SDBone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament. |
| Exercise Therapy | Active comparator | Other: Exercise TherapySubjects will be instructed in a set of appropriate knee strengthening exercises and given an instructional hand-out to take home. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenexx SDstem cell treatment | Procedure or surgery | Regenexx SD |
| Exercise Therapyexercise therapy control | Other | Exercise Therapy |
Primary outcome
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.
6 secondary outcomes
Mean Pain Scales
Time frame: 3, 6, 12 and 24 months
Magnetic Resonance Evaluation of ligament repair
Time frame: 6 months
Mean IKDC Subjective Knee Evaluation Scores
Time frame: 6, 12 and 24 months
Incidence of complications and adverse events
Time frame: 24 months
Incidence of re-injection and surgical revision
Time frame: 24 months
Use of pain medications
Time frame: 3, 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Derived from this study: PubMed 41029301Centeno 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.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Tear
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Recruiting
Quadriceps Strengthening ACL Reconstruction
ACL Tear
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Centeno, MD principal investigator
Centeno-Schultz Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenexx SD and Exercise Therapy in people with Anterior Cruciate Ligament Tear, run by Regenexx, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IKDC Subjective Knee Evaluation Score Change from Baseline (time frame: Change from Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01850758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.