RecruitingPhase 1NCT06798623

Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells

Sponsor

The Methodist Hospital Research Institute

Enrollment

15 participants

Start Date

Mar 24, 2026

Study Type

INTERVENTIONAL

Conditions

Anterior cruciate ligament reconstruction

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria15

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)

Interested in this trial?

Get notified about updates and connect with the research team.

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.