Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Anterior Cruciate Ligament Reconstruction (BMAC)
Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injury focused on measuring Anterior Cruciate Ligament, ACL, Stem Cell, Mesenchymal stem cells, biologic, augmentation
Eligibility Criteria
Inclusion Criteria:
- English-speaking patients
- 18-60 years of age with acute ACL injury (<6 months from time of injury to reconstruction) and undergoing reconstruction with patellar tendon allograft
- Written informed consent is obtained
Exclusion Criteria:
- Revision Surgery
- Prior history of knee surgery
- Concomitant ligamentous injury
- Inability to obtain an MRI
- Inability to participate in follow-up for the study
- Any patient lacking decisional capability
- Diagnosed musculoskeletal cancer or any diagnosed cancer, other than
- musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
- Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection or use of systemic steroids)
- Known history of HIV, or has active Hepatitis B or active Hepatitis C
- Alcohol and drug (medication) abuse
- Pregnant or breast feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
- Patients that have received PRP, other platelet-based product, or investigational treatment in another cell/biologic study for the target knee in the 12 months prior to the injection procedure
- Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
- Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Mesenchymal Stem Cell Recipient
Control Sham Incision
Patients in this group will receive between 1-4 ml of bone marrow aspirate concentrate (BMAC) containing mesenchymal stem cells (MSCs) obtained from their iliac crest. A small incision will be made on the anterior superior iliac spine in order to withdraw the aspirate. The aspirate will be ran through a centrifuge in order to isolate the BMAC containing MSCs. The BMAC will be injected into the ACL allograft prior to implanting into the patient.
Patients will receive a sham incision on the anterior superior iliac spine where the bone marrow aspirate is obtained in the the experimental group. This ensures proper blinding. The patient will receive the normal standard of care.