Status:
RECRUITING
Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Anterior Cruciate Ligament Reconstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 su...
Eligibility 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)
Key Trial Info
Start Date :
March 24 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06798623
Start Date
March 24 2026
End Date
March 1 2030
Last Update
April 16 2026
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030