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NCT06798623 | RECRUITING | Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
Sponsor:

The Methodist Hospital Research Institute

Information provided by (Responsible Party):

Patrick McCulloch,MD

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 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.

Condition or disease

Anterior Cruciate Ligament Reconstruction

Intervention/treatment

Autologous Mesenchymal Stromal Cells

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2028-03
Estimated Study Completion Date : 2030-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction 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
Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells

Location Details

NCT06798623

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How to Participate

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Locations

RECRUITING

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030