Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing CARTISTEM® + Debridement for Knee Cartilage Defects

This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis. CARTISTEM is a new treatment made of stem cells from donated umbilical cord blood mixed with a gel (hyaluronic acid) that is placed in the damaged area of the knee The main goal is to find out if CARTISTEM® reduces knee pain and improves knee function more than debridement two years after treatment.

Official registry: https://clinicaltrials.gov/study/NCT07339111 · Medipost, Inc. · enrollment listed as 300

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CARTISTEM® + Debridement, or Debridement. The registry lists allocation as randomized. This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis.

They plan to enroll about 300 people at 37 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

Randomized, Prospective, Double Blind, Multi-Center, Phase 3 Pivotal Clinical Trial to Compare Efficacy and Safety of CARTISTEM® and Surgical Comparator in Subjects With Knee Cartilage Lesions and Osteoarthritis

Interventions: CARTISTEM® + Debridement, Debridement

Primary outcome (registry wording): Visual Analog Scale (VAS) Pain Score

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • Age ≥ 18 and ≤ 75 years old
  • Knee Osteoarthritis diagnosed in the index knee according to the clinical definition of American College of Rheumatology (ACR) guidelines at screening
  • Failed conservative knee osteoarthritis treatment for at least 3 months prior to consent (weight reduction, physical therapy, injections, pain medications, etc.)
  • Kellgren-Lawrence (KL) in the index knee of grade 2 to 3 as determined by independent radiologist review of study X-Ray
  • Clinically relevant femoral cartilage defects classified using modified Outerbridge Grade 3 or 4 in index knee with combined lesion area ≥ 2 cm2 and ≤ 9 cm2 and at least a single femoral lesion ≥ 2 cm2 as determined by independent radiologist review of study MRI
  • Body Mass Index (body-mass index (BMI)) ≤ 35 kg / m2
  • VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at screening

Public study contact (from the registry)

Adrian Orr, VP Clinical Development

617-575-2203

cartistem2023-01@medi-post.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

37 listed

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FAQ about this NCT record

Is NCT07339111 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07339111?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07339111?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary