Clinical trial NCT06798623: Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
Official title: Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop
measure: Knee Function
timeFrame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop
measure: Knee Function
timeFrame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop
measure: Knee Function
timeFrame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop
Secondary outcomes:
measure: Knee Pain
timeFrame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop
measure: Return to Sport Time
timeFrame: 3 months postop
measure: Knee Swelling
timeFrame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop
measure: Knee Pain
timeFrame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop
Other outcomes:
Locations:
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Patrick McCulloch, MD
role: PRINCIPAL_INVESTIGATOR
References: