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New treatment option for Anterior Cruciate Ligament Reconstruction
Official title Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells
ClinicalTrials.gov ID: NCT06798623
What this study is testing
What is Autologous Mesenchymal Stromal Cells?
Autologous Mesenchymal Stromal Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for anterior cruciate ligament reconstruction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar...
- Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.
You likely can't join if
- 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...
- Unable to attend physical therapy at Houston Methodist
- Vulnerable populations
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.