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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenexx SD | Active Comparator | Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regenexx SD | Procedure | stem cell treatment |
| |
| Exercise Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Scales | Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint | 3, 6, 12 and 24 months |
| Magnetic Resonance Evaluation of ligament repair | Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Centeno, MD | Centeno-Schultz Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centeno-Schultz Clinic | Broomfield | Colorado | 80021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41029301 | Derived | 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. |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Other |
exercise therapy control |
|
| 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. | 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. | 24 months |
| Incidence of re-injection and surgical revision | Incidence of and time to re-injection and surgical revision between treatment groups. | 24 months |
| Use of pain medications | Difference between treatment groups in use of pain medications at each follow-up timepoint | 3, 6, 12 and 24 months |
| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |