ACL reconstruction using your own knee fat–derived stem cells
Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
This will try a single injection of your own mesenchymal stem cells taken from the fat under the kneecap to see if it is safe and helps recovery after ACL reconstruction with a patellar tendon autograft.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06798623 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open‑label, single‑arm Phase 1 pilot in which each participant undergoing ACL reconstruction will have infrapatellar fat pad tissue collected during surgery and a single intra‑articular injection of autologous mesenchymal stromal cells. The study will enroll adults having bone‑to‑bone patellar tendon autograft performed by the Principal Investigator and who plan to do post‑operative physical therapy at Houston Methodist clinics. Primary focus is safety with collection of preliminary signals of efficacy on healing and functional recovery. Exclusion criteria include prior surgery on the affected knee, diabetes, immunocompromise, active infection, significant heart disease, pregnancy, non‑English speakers, inability to attend local PT, or other procedures the PI deems exclusionary.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for ACL reconstruction using a bone‑to‑bone patellar tendon autograft with the study surgeon and able to attend post‑op physical therapy at Houston Methodist are ideal candidates.
Not a fit: Patients with prior surgery on the affected knee, diabetes, immunosuppression, active infection, significant heart disease, pregnancy, inability to attend Houston Methodist PT, or other excluded conditions are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could lower inflammation and improve graft healing and functional recovery after ACL reconstruction.
How similar studies have performed: Small preclinical and pilot clinical work with fat‑ or bone‑marrow‑derived mesenchymal stromal cells in knee injuries has shown safety and some functional improvements, but high‑quality randomized evidence specifically in ACL reconstruction remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Patrick McCulloch, MD — The Methodist Hospital Research Institute
- Study coordinator: Madison Bowden
- Email: mmbowden@houstonmethodist.org
- Phone: 713-363-7390
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.