Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT01850758
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regenexx™ SD Versus Exercise Therapy for ACL Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2013-05-07', 'studyFirstSubmitQcDate': '2013-05-07', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IKDC Subjective Knee Evaluation Score Change from Baseline', 'timeFrame': 'Change from Baseline to 3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean Pain Scales', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint'}, {'measure': 'Magnetic Resonance Evaluation of ligament repair', 'timeFrame': '6 months', 'description': 'Comparison of Magnetic Resonance Evaluation of ligament repair at 6 months'}, {'measure': 'Mean IKDC Subjective Knee Evaluation Scores', 'timeFrame': '6, 12 and 24 months', 'description': 'Difference between treatment groups in mean KDC Subjective Knee Evaluation Scores at 6, 12 and 24 months.'}, {'measure': 'Incidence of complications and adverse events', 'timeFrame': '24 months', 'description': 'Incidence and time to resolution of post-operative complications and adverse events between treatment groups.'}, {'measure': 'Incidence of re-injection and surgical revision', 'timeFrame': '24 months', 'description': 'Incidence of and time to re-injection and surgical revision between treatment groups.'}, {'measure': 'Use of pain medications', 'timeFrame': '3, 6, 12 and 24 months', 'description': 'Difference between treatment groups in use of pain medications at each follow-up timepoint'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ACL', 'Anterior Cruciate Ligament', 'ACL Tear', 'Anterior Cruciate Ligament Tear', 'Partial ACL Tear'], 'conditions': ['Anterior Cruciate Ligament Tear']}, 'referencesModule': {'references': [{'pmid': '41029301', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSecondary 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.', 'detailedDescription': '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.\n\nSubjects will have a partial or complete, non-retracted ACL ligament tear as evidenced with MRI.\n\nSubjects 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n* Physical examination consistent with lax ACL ligament (Anterior Drawer Test)\n* Abnormal Telos Arthrometer measurement\n* 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.\n* Full range of motion of the affected knee (other than restriction clearly due to effusion)\n* Normal range of motion of the non-treated knee\n* Is independent, ambulatory, and can comply with all post-operative evaluations and visits\n\nExclusion Criteria:\n\n* A massive ACL tear or one that includes more than 2/3'rds of the ligament that's retracted.\n* Previous surgery to the affected ACL (i.e. previous ACL replacement with an autograft or allograft)\n* Prior ACL prolotherapy, PRP, corticosteroid injection or other injection therapy within the past three months,\n* 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).\n* Concomitant PCL or LCL tears\n* 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)\n* Quinolone or Statin induced myopathy/ tendinopathy\n* Kellgren-Lawrence grade 2 or greater knee osteoarthritis\n* Significant knee extension lag compared to the opposite knee\n* Symptomatic lumbar spine pathology (e.g. radicular pain)\n* Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh\n* Contraindications for MRI\n* 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\n* Condition represents a worker's compensation case\n* Currently involved in a health-related litigation procedure\n* Is pregnant\n* Bleeding disorders\n* Currently taking anticoagulant or immunosuppressive medication\n* Allergy or intolerance to study medication\n* Use of chronic opioid,"}, 'identificationModule': {'nctId': 'NCT01850758', 'briefTitle': 'Regenexx™ SD Versus Exercise Therapy for ACL Tears', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regenexx, LLC'}, 'officialTitle': 'A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Partial and Complete, Non-retracted Anterior Cruciate Ligament Tears', 'orgStudyIdInfo': {'id': 'RSI2013-RCT01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Regenexx SD', 'description': 'Bone Marrow Aspirate Concentrate injected under imaging guidance into the area of the damaged ligament.', 'interventionNames': ['Procedure: Regenexx SD']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Therapy', 'description': 'Subjects will be instructed in a set of appropriate knee strengthening exercises and given an instructional hand-out to take home.', 'interventionNames': ['Other: Exercise Therapy']}], 'interventions': [{'name': 'Regenexx SD', 'type': 'PROCEDURE', 'description': 'stem cell treatment', 'armGroupLabels': ['Regenexx SD']}, {'name': 'Exercise Therapy', 'type': 'OTHER', 'description': 'exercise therapy control', 'armGroupLabels': ['Exercise Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80021', 'city': 'Broomfield', 'state': 'Colorado', 'country': 'United States', 'facility': 'Centeno-Schultz Clinic', 'geoPoint': {'lat': 39.92054, 'lon': -105.08665}}], 'overallOfficials': [{'name': 'Christopher Centeno, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centeno-Schultz Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regenexx, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}