RECRUITING

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

Conditions

Anterior Cruciate Ligament Reconstruction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-08

Study Completion:2030-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06798623

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

David Armond

CONTACT

346-238-0206

dnarmond@houstonmethodist.org

Haley Goble

CONTACT

713-441-3930

hmgoble@houstonmethodist.org

Principal Investigator

Patrick McCulloch, MD

PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Study Locations (Sites)

Houston Methodist Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2030-03

Study Record Updates

Study Start Date2025-08

Study Completion Date2030-03

Terms related to this study

Additional Relevant MeSH Terms

Anterior Cruciate Ligament Reconstruction