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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Page 1 of 1 (1 locations)

1

Houston Methodist Hospital

Houston, Texas, United States, 77030

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