RECRUITING

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

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.

Conditions

Anterior Cruciate Ligament Reconstruction
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Anterior Cruciate Ligament Reconstruction

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Anterior Cruciate Ligament Reconstruction
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Methodist Hospital Research Institute,

Patrick McCulloch, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

2030-03