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Knee Cartilage DefectsPhase 3CARTISTEM23-01NCT07339111

Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis

A Phase 3 study testing CARTISTEM® + Debridement and Debridement in people with Knee Cartilage Defects, run by Medipost, Inc. at 35 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To establish the efficacy and safety of CARTISTEM®, a combination product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel, CARTISTEM® compared to the surgical comparator of debridement in Subjects with knee… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Knee Cartilage Defects
What is being tested?
CARTISTEM® + Debridement and Debridement
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
35 sitesUnited States
Study dates
11 Mar 2026to 30 Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (BMI) ≤ 35 kg / m2 .
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  • VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at screening.
  • VAS PAIN contralateral knee score ≤ 30 based on 100-point scale at screening.
  • WOMAC® FUNCTION index knee mean score ≥ 25 to ≤ 90 based on 100-point scale at screening.
  • WOMAC® Pain index knee mean score ≥ 40 to ≤ 90 based on 100-point VAS (visual analogue scale) at screening.
  • Subjects must be willing to abstain from treatments in the index knee from the time the informed consent is signed until after the last study follow up visit.
  • Subjects must be willing to discontinue analgesics except:
  • Rescue medication (acetaminophen) allowed for break-through pain throughout the study.
  • Subjects must be willing to discontinue use of all pain medications at least 48 hours prior to baseline assessment and each follow up visit.
  • Limited postoperative NSAID use is permissible per IND clinical guidance and site manual, provided washout before scheduled efficacy assessments.
  • Post operative narcotics.
  • Subjects with stage 3 hypertension (systolic ≥ 180 mm Hg and diastolic ≥ 120 mmHg) must have blood pressure (BP) controlled prior to surgical procedure.
  • Subject's central lab results are within normal ranges or deemed as not clinically significant by investigator for CARTISTEM® treatment or surgical comparator.
  • Female Subjects of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study.
  • Subjects must be able to comply fully with the rehabilitation requirements.
  • Subjects must be able to understand and comply with the requirements of the study.
  • Subjects must voluntarily provide written informed consent.

Who cannot join

  • Subject received an IA injection of Hyaluronic Acid (HA), Platelet Rich Plasma (PRP), Bone Marrow Aspirate / Concentrate (BMA / BMAC), long-acting / conventional steroid, or investigational drug in either knee within 3 months of signing informed consent. Note: injections of the contralateral knee are allowed during the trial.
  • Bone marrow lesion (BML) grade 3 on femur, tibia, or patella except at femoral lesion area (BML grade 3 allowed) in index knee as determined by independent radiologist review of study MRI.
  • KL index knee grade 0, 1 or 4 as determined by independent radiologist review of study X-Ray.
  • KL Contralateral knee severity grade 4 as determined by independent radiologist review of study X-Ray.
  • Anatomical axis varus or valgus malalignment ≥ 6° in either knee as determined by independent radiologist.
  • Joint ligament instability in index knee ≥ Grade 3 or ligament instability that would require surgical intervention as determined by investigator or designee.
Show all 42Show fewer
  • Complete meniscal deficiency, meniscal root tears and / or severe meniscal extrusion as determined by independent radiologist.
  • Kissing bipolar lesions (tibial or patellar) Outerbridge 4 exceeding 25% of the femoral lesion area in size and/or penetrating through the subchondral bone as determined by independent radiologist.
  • Surgery of the index knee joint within 6 months of signing the informed consent. Investigator confirms that Subject has recovered from any prior surgical intervention to enable treatment within this study protocol. No radiation therapy of the index knee as determined by documented medical history.
  • Chronic inflammatory articular diseases such as rheumatoid arthritis, gout, pseudogout, gouty arthritis, or fibromyalgia as determined by documented medical history.
  • Bone disorders of index knee: osteonecrosis including avascular necrosis (AVN); Osteochondritis dissecans (OCD); Spontaneous Osteonecrosis of the Knee (SONK); Subchondral Insufficiency Fracture (SIF); Subchondral / intraosseous bone cyst >4mm at femoral treatment location, bone tumors, bone contusion or stress fracture, pathologic fracture, and other bone exclusionary findings as determined by independent radiologist review of study MRI or X-ray.
  • Joint disorders of the index knee including infection, osteomyelitis, soft tissue tumors, and bone marrow infiltration as determined by independent radiologist review of study MRI or X-ray.
  • Diseases or disorders including Paget's disease, ochronosis, acromegaly, haemochromatosis, Wilson's disease, genetic disease (hyperkinesia, etc.), or genetic collagen disorder as determined by documented medical history.
  • Vascular or neurological disorders of the lower extremities as determined by documented medical history. Note: Varicose veins are not an exclusion criteria.
  • Autoimmune diseases - documented medical history. Addison's Disease, Dermatomyositis, Irritable Bowel Diseases (IBD) or Irritable Bowel Syndrome (IBS) (including Crohn's disease and ulcerative colitis), Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Rheumatoid Arthritis, Sjogren's Syndrome, systemic Lupus erythematosus. Note: Celiac disease is not an exclusion criterion.
  • Subject has documented systemic diseases such as but not limited to HIV, hepatitis, HTVL, syphilis, and blood coagulopathies (including hemophilia, Von Willebrand disease, thrombocytopenia, disseminated intravascular coagulation (DIC)). Note: Occurrence of Deep Vein Thrombosis ≥ 5 years prior to consent is not an exclusion.
  • Subject is taking anticoagulant medication (e.g., warfarin, (Coumadin), apixaban (Eliquis), rivaroxaban (Xarelto), clopidogrel (Plavix) or equivalent) but not excluding 81mg aspirin.
  • Uncontrolled diabetes with HbA1c > 8% as determined by documented medical history.
  • Infectious disease requiring parenteral administration of antibiotics.
  • Administered immunosuppressants such as Cyclosporin A or azathioprine within 6 months of signing the informed consent.
  • Subject has received chemotherapy in the 12 months prior to signing informed consent.
  • Subject has received other allogeneic stem cell therapy.
  • Prior cartilage repair procedure (such as MACI, ACI, OATS, OCA, Agili-C) in the index knee or the index knee contains a uni-compartmental knee replacement. Revision of a prior microfracture procedure is allowed if subchondral plate remains intact and lesion is lacking significant intra-lesional osteophytes.
  • Prior invasive knee osteoarthritis treatment including subchondroplasty, cryoneurolysis, genicular nerve ablation, genicular artery embolization, in situ MISHA (medial knee implanted shock absorber), prosthetic implants or other knee implants or invasive treatments for the index knee.
  • Known history of hypersensitivity / allergy to hyaluronan.
  • Currently pregnant or nursing.
  • Psychotic diseases, epilepsy, or any history of such diseases.
  • Known substance or alcohol abuse in the prior 3 years.
  • Contraindication to MRI imaging or unwillingness to undergo MRI.
  • Currently receiving or in litigation related to workman's compensation, personal injury, or disability claims.
  • Considered by principal investigator inappropriate for the clinical trial due to any reasons other than those listed above.
  • Baseline PRO Assessment Inclusion Criteria:
  • VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at baseline PRO assessment.
  • WOMAC® FUNCTION index knee mean score ≥ 25 to ≤ 90 based on 100-point scale at baseline PRO assessment.
  • Baseline Surgical Inclusion Criteria:
  • 1. Treated cartilage defects Outerbridge Grade 3 or 4 in index knee with combined femoral lesion area ≤ 9 cm2 as determined arthroscopically or by arthrotomy by treating physician.
  • Baseline Surgical Exclusion Criteria:
  • Meniscal root tears and / or severe meniscal extrusion or non-functional meniscus as determined arthroscopically or by arthrotomy by treating physician.
  • Kissing bipolar lesions (tibial or patellar) Outerbridge 4 exceeding 25% of the femoral lesion area in size and/or penetrating through the subchondral bone as determined arthroscopically or by arthrotomy by treating physician.
  • Bone or joint disorders of the index knee including infection, osteomyelitis, soft tissue tumors, bone marrow infiltration, osteonecrosis (AVN or OCD) as determined arthroscopically or by arthrotomy by treating physician.
  • Identification of prior cartilage repair procedure (such as MACI, ACI, OATS, OCA, Agili-C) or uni-compartmental knee replacement in the index knee as determined arthroscopically or by arthrotomy by treating physician. Revision of a prior microfracture procedure is allowed if subchondral bone remains intact and lacking significant intra-lesional osteophytes.
  • Subject is documented as pregnant based on hCG urine or blood test prior to surgery.

Trial locations and contacts

35 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Adrian Orr, VP Clinical Development contact

617-575-2203

cartistem2023-01@medi-post.com

Luis Toro, Medical Monitor for IQVIA, MD contact

35 sites in 1 country

United States35 sites, 34 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48106

    Christopher Ray, 734-615-0934, raychri@med.umich.edu

    John Grant, MD

    Recruiting

  • Flourish Research Birmingham

    Birmingham, Alabama, 35205

    Shannon Helton, 205-208-9244, SHelton@flourishresearch.com

    Jeffery Davis, MD

    Recruiting

  • Atrium Health Mercy

    Charlotte, North Carolina, 28207

    Mario Cuadra, 7043045000, MyAtriumHealth@atriumhealth.org

    Claude Moorman, MD

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Cole Brian, MD, 312-432-2818, cole.research@rushortho.com

    Brian Cole, MD

    Recruiting

  • University of Cincinnati Department of Orthopaedic Surgery

    Cincinnati, Ohio, 45267

    Rebekah West, 5135566000, westrk@ucmail.uc.edu

    Brian Grawe, MD

    Recruiting

  • The Ohio State University Jameson Crane Sports Medicine Institute

    Columbus, Ohio, 43202

    Jenna DeFranco, 614-293-2001, jenna.defranco@osumc.edu

    Jelle Van Der List, MD

    Recruiting

  • Zenos Clinical Research

    Dallas, Texas, 75230

    Lizbeth Delgado Velasquez, 469-949-4900, mglasco@allianceclinicalnetwork.com

    Howsen Kwan, MD

    Recruiting

  • Advanced Research

    Deerfield Beach, Florida, 33064

    Manish Gupta, MD

    Recruiting

  • Sports and Orthopedic Center

    Deerfield Beach, Florida, 33064

    Jay Patel, 954-302-3139, jpatel@advancedresearchfl.com

    Manish Gupta, MD

    Recruiting

  • TriWest Research Associates

    El Cajon, California, 91910

    Stephanie Soto, 619-334-4735, ssoto@triwestresearch.com

    Arthur Mabaquiao, MD

    Recruiting

  • CORE Orthopaedic Medical Center

    Encinitas, California, 92024

    Farouk Awad, 760-943-6700, fawad@coreorthopaedic.com

    Nathan Hammel, MD

    Recruiting

  • New York Presbyterian Queens

    Flushing, New York, 11355

    Susan Ingenito, (718) 670-2414, sui9006@nyp.org

    Tony Quach, MD

    Recruiting

  • Memorial Hermann Center

    Houston, Texas, 77043

    Alan Eguia, (713) 222-2273, jcarr@ergclinical.com

    Dominick D'Aunno, MD

    Recruiting

  • HD Research Corp.

    Houston, Texas, 77401

    Bader Hamoud, 713-367-8548, BHamoud@ergclinical.com

    Daneshvari Solanki, MD

    Recruiting

  • Helios Clinical Research

    Jackson, Tennessee, 38305

    William Edwards, 731-426-5380, william.edwards@heliosclinical.com

    Jason Hutchinson, MD

    Recruiting

  • Ochsner Medical Center

    Kenner, Louisiana, 70065

    Jasmine Warren, 504-703-5884, jasmine.warren@ochsner.org

    Vinod Dasa, MD

    Recruiting

  • Horizon Clinical Research - La Jolla

    La Jolla, California, 92122

    Dino Subasic, 858-539-1184, dino@horizontrials.com

    Michael Bogard, MD

    Recruiting

  • Horizon Clinical Research

    La Mesa, California, 91924

    Dino Subasic, (619) 456-6012, dino@horizontrials.com

    Scott Hacker, MD

    Recruiting

  • UK Orthopaedic Surgery & Sports Medicine - Turfland

    Lexington, Kentucky, 40504

    Jennifer Douyere, 859-257-1000, jennifer.douyere@uky.edu

    Austin Stone, MD

    Recruiting

  • Futuro Clinical Trials

    McAllen, Texas, 78501

    Carlos Del Angel, 956-999-8399, cdelangel@futuroct.com

    Felipe Gomez-Escadon, MD

    Recruiting

  • West Clinical Research

    Morehead City, North Carolina, 28557

    Millicent Clark, 252-515-0050, info@westclinicalresearch.com

    Jeffery Moore, MD

    Recruiting

  • NYU Langone Orthopedic Center

    New York, New York, 10016

    Riley McConnell, 646-831-8314, riley.mcconnell@nyulangone.org

    Alexander Golant, MD, 929-455-2000, Alexander.Golant@nyulangone.org

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Active, not recruiting

  • Orthopedic Centers of Colorado

    Parker, Colorado, 80134

    Abby Watkins, 3033449090, Newmanresearch@occ-ortho.com

    Justin Newman, MD

    Recruiting

  • Stanford University - Department of Orthopaedic Surgery

    Redwood City, California, 94063

    Allen Seo, 650-721-7645, allenseo@stanford.edu

    Seth Sherman, MD

    Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

    Noelle Drapeau, 507-266-6397, Drapeau.Noelle2@mayo.edu

    Daniel Saris, MD

    Recruiting

  • Michigan Orthopedics and Spine Surgery

    Rochester Hills, Michigan, 48307

    Cecile Pestano, 248-215-8080, mossclinicalresearch@gmail.com

    Nathan Rimmke, MD

    Recruiting

  • JBR Clinical Research

    Salt Lake City, Utah, 84107

    Heather Hilliard, 801-261-2000, h.hilliard@cenexel.com

    Todd Bertoch, MD

    Recruiting

  • Flourish Research San Antonio

    San Antonio, Texas, 78229

    LaToya Gates, 210-714-0067, lgates@flourishresearch.com

    Douglas Denham, MD

    Recruiting

  • Endeavor Clinical Trials, P.A (ERG)

    San Antonio, Texas, 78240

    Chelsey Lanier, 2109490807, clanier@ergclinical.com

    Nitendra Agarwal, MD

    Recruiting

  • Source Healthcare

    Santa Monica, California, 90403

    Shannon Zhu, 310-574-2777 ext. 33, shannon@sourcehealthcare.com

    Omar Rahman, MD

    Recruiting

  • Scottsdale Clinical Trials, LLC - Elite Clinical Network

    Scottsdale, Arizona, 85260

    Lisette Partipilo, 4803827909, lpartipilo@scottsdaletrials.com

    Todd Dreitzler, MD

    Recruiting

  • Steamboat Orthopaedic and Spine Institute

    Steamboat Springs, Colorado, 80487

    Heidi Mueller, 970 500-5215, hmueller@steamboatortho.com

    Alexander Meininger, MD

    Recruiting

  • AZ Orthopedic

    Tempe, Arizona, 85224

    Khrystya Mala, 480-659-7147, larcuri@macoa-health.com

    Eric Eifler, MD

    Recruiting

  • Curalta Clinical Trials

    Westwood, New Jersey, 07662

    Harrison Miller, 888-777-1430, hmiller@curalta.com

    Vincent Giacalone, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

To establish the efficacy and safety of CARTISTEM®, a combination product composed of allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) formulated with a cross-linked sodium hyaluronate (HA) hydrogel, CARTISTEM® compared to the surgical comparator of debridement in Subjects with knee cartilage lesions and osteoarthritis.

This trial is intended to provide evidence of the superiority of CARTISTEM® to reduce knee pain and improve knee function compared to debridement for Subjects with knee cartilage lesions and osteoarthritis at 2-years post-treatment.

Additionally, this trial is intended to intended to explore whether CARTISTEM® may have disease-modifying effects on osteoarthritis progression through the use of semi-quantitative MRI assessment.

Being tested
CARTISTEM® + Debridement, Debridement
Keywords
symptomatic knee cartilage defects, knee cartilage, cartilage repair, osteoarthritis
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CARTISTEM® + DebridementBiological

    CARTISTEM® + Debridement

    CARTISTEM® consists of approximately 7.5 x 106 hUCB-MSCs (human umbilical cord blood-derived mesenchymal stem/stromal cells) suspended in 1.5 ml medium in one vial, and 60 mg sodium hyaluronate provided as a lyophilized powder in a separate vial.

    A viscous and malleable gel matrix is formed by mixing hUCB-MSCs (main component) and 60mg of sodium hyaluronate at a 4% concentration (excipient).

  • DebridementProcedure or surgery

    Debridement of unstable cartilage in and around cartilage lesion(s) in the knee.

Study groups in NCT07339111
Study groupRoleWhat they receive
CARTISTEM + DebridementExperimentalParticipants in Group A will receive CARTISTEM + Debridement in the target knee.
Receives: Biological: CARTISTEM® + Debridement
DebridementActive comparatorParticipants in Group B will receive debridement procedure.
Receives: Procedure: Debridement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale (VAS) Pain Score

    Change from Baseline Visual Analog Scale (VAS) Pain score (0-100 point scale, 0 being no pain at one end and 100 being the worst imaginable pain at the other) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.

    Measured: From enrollment to end of follow-up at 24 months

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score

    Change from Baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score (0-100 point scale, 0 being the best functioning and 100 being the worst functioning) in index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.

    Measured: From start of treatment to the end of follow-up at 24 months

Secondary outcomes (2)

  1. Modified Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score

    Change in modified MOCART score in Index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.

    Measured: enrollment to follow-up at 24 months.

  2. Change in MRI Osteoarthritis Knee Score (MOAKS) cartilage morphology

    Change in MOAKS cartilage morphology with delta sum score - extent of cartilage damage score in Index knee comparing CARTISTEM® to surgical control at 24-months post-treatment.

    Measured: enrollment to follow up at 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start11 Mar 2026
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07339111
Sponsor's protocol ID
MPA-CARTISTEM-2023-01
Acronym
CARTISTEM23-01
Status last verified
Oct 2026
First submitted
9 Jan 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CARTISTEM® + Debridement and Debridement in people with Knee Cartilage Defects, run by Medipost, Inc. at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adrian Orr, VP Clinical Development (617-575-2203, cartistem2023-01@medi-post.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) Pain Score (time frame: From enrollment to end of follow-up at 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07339111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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