Overview
This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.
Eligibility
Inclusion Criteria:
- Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with the Principal Investigator (PI).
- Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.
Exclusion Criteria:
- Under 18 years of age
- Prior surgery on affected knee
- Diabetes
- Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary
- Unable to attend physical therapy at Houston Methodist
- Vulnerable populations
- Immunocompromised patients such as those being treated for cancer, kidney failure, etc.
- Heart disease including (systolic blood pressure >180 mm Hg or heart failure)
- Active infections
- Non-English-speaking patients
- Any known metal implants or allergy to contrast agents
- Pregnancy (as part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative result is required to proceed with surgery per SOC and thus, participate in the study) and those planning to become pregnant during the duration of the study
- Any condition with known bleeding disorders, thrombus formation risk factors, or overlying wound and skin infections
- Any condition in the opinion of the primary investigator that would compromise the integrity of the data collection or outcomes being assessed