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Recruiting NCT06798623

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

Phase I Interventional Anterior Cruciate Ligament Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Mesenchymal Stromal Cells.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Reconstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Biological Autologous Mesenchymal Stromal Cells
    Autologous mesenchymal stromal/stem cells extracted from the subject during a routine standard of care ACL reconstruction surgery and reintroduced in one clinic visit approximately 21 days after completion of the surgery. After being removed from the patient, the cells will be cultured, modified, and harvested to become the final investigational product. Each subject will receive 1.5 ml of the investigative drug. This will contain 5x10\^7 (50 million) autologous MSCs.

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events [Time frame: 4-5 weeks postop, 6-7 weeks postop, 3.5 months postop, 6 months postop]
  • Knee Function [Time frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop]
  • Knee Function [Time frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop]
  • Knee Function [Time frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop]
Secondary outcome measures (4)
  • Knee Pain [Time frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop]
  • Return to Sport Time [Time frame: 3 months postop]
  • Knee Swelling [Time frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop]
  • Knee Pain [Time frame: Preoperative appointment, 6 weeks postop, 3.5 months postop, 6 months postop]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Houston Methodist Hospital — Houston

Identifiers

NCT: NCT06798623 · Pro00039160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗