Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
The Methodist Hospital Research Institute
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar tendon autograft 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…
Interventions
- BiologicalAutologous Mesenchymal Stromal Cells
Autologous mesenchymal stromal/stem cells extracted from the subject during a routine standard of care ACL reconstruction surgery and reintroduced in one clinic visit approximately 21 days after completion of the surgery. After being removed from the patient, the cells will be cultured, modified, and harvested to become the final investigational product. Each subject will receive 1.5 ml of the investigative drug. This will contain 5x10\^7 (50 million) autologous MSCs.
Location
- Houston Methodist HospitalHouston, Texas