NCT06798623 · The Methodist Hospital Research Institute
Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
What this study is about
This study is designed as a forward-looking, open label, single treatment group$1 pilot clinical study that will establish the safety and effectiveness of a single injection of mesenchymal stromal cells in patients.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations