NCT06798623PHASE1Recruiting
Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
The Methodist Hospital Research Institute
Start Date
3/24/2026
Completion Date
3/1/2030
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 Criteria
Age Range: 18 years to No maximum
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 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
* Any other medical condition that in the opinion of the primary investigator would constitute a relative contraindication to study participation (e.g., Ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, SLE, scleroderma, polymyositis, Ehlers-Danlos syndrome, osteoporosis)
Interventions
BIOLOGICAL
Autologous Mesenchymal Stromal Cells
Conditions
Anterior Cruciate Ligament Reconstruction
Locations
Houston Methodist Hospital
Houston, Texas 77030
United States