ACL reconstruction using your own knee fat–derived stem cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.