Actively Recruiting
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Led by Medipost, Inc. · Updated on 2026-05-08
300
Participants Needed
16
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Diagnosed knee osteoarthritis in the affected knee per American College of Rheumatology guidelines
- Failed conservative knee osteoarthritis treatments for at least 3 months
- Kellgren-Lawrence grade 2 or 3 in the affected knee
- Femoral cartilage defects classified as Outerbridge Grade 3 or 4 with lesion area between 2 and 9 cm2, including at least one lesion 2 cm2 or larger
- Body Mass Index (BMI) of 35 kg/m2 or less
- Visual Analog Scale (VAS) pain score in the affected knee between 40 and 90 (100-point scale)
- VAS pain score in the opposite knee 30 or less
- WOMAC4 function score between 25 and 90 (100-point scale)
- WOMAC4 pain score between 40 and 90 (100-point scale)
- Willingness to avoid treatments in the affected knee from consent until study end
- Willingness to discontinue analgesics except allowed rescue medication and limited NSAID use per protocol
- Controlled blood pressure if diagnosed with stage 3 hypertension
- Normal or clinically acceptable lab results
- Female participants of childbearing potential must use effective birth control
- Ability to comply with rehabilitation and study requirements
- Ability to provide informed consent
You will not qualify if you...
- Intra-articular injection of hyaluronic acid, platelet-rich plasma, bone marrow aspirate/concentrate, steroids, or investigational drugs in either knee within 3 months before consent
- Bone marrow lesion grade 3 outside femoral lesion area in affected knee
- Kellgren-Lawrence grade 0, 1 or 4 in affected knee or grade 4 in opposite knee
- Knee malalignment of 6 degrees or more in either knee
- Joint ligament instability grade 3 or requiring surgery in affected knee
- Complete meniscal deficiency, meniscal root tears, or severe meniscal extrusion
- Large kissing bipolar lesions exceeding 25% of femoral lesion area or penetrating subchondral bone
- Knee surgery within 6 months before consent or radiation therapy to affected knee
- Chronic inflammatory joint diseases like rheumatoid arthritis, gout, fibromyalgia
- Bone disorders such as osteonecrosis, osteochondritis dissecans, bone tumors, fractures
- Joint infections or tumors in the affected knee
- Certain systemic diseases including Paget's disease, acromegaly, genetic collagen disorders
- Vascular or neurological disorders of lower limbs (varicose veins not excluded)
- Autoimmune diseases such as Addison's disease, multiple sclerosis, lupus (celiac disease is allowed)
- Systemic infections like HIV, hepatitis, syphilis, or blood clotting disorders
- Use of anticoagulant medications except low-dose aspirin
- Uncontrolled diabetes with HbA1c over 8%
- Infectious diseases requiring IV antibiotics
- Recent use of immunosuppressants or chemotherapy
- Previous allogeneic stem cell therapy
- Prior cartilage repair surgeries or knee replacements in affected knee (some exceptions)
- Known allergy to hyaluronan
- Pregnancy or nursing
- Psychotic diseases, epilepsy, or recent substance/alcohol abuse
- Contraindication to MRI or unwillingness to have MRI
- Current litigation related to workman's compensation or disability
- Any other reason the investigator deems unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Flourish Research Birmingham
Birmingham, Alabama, United States, 35205
Actively Recruiting
2
AZ Orthopedic
Tempe, Arizona, United States, 85224
Actively Recruiting
3
TriWest Research Associates
El Cajon, California, United States, 91910
Not Yet Recruiting
4
Horizon Clinical Research
La Mesa, California, United States, 91924
Not Yet Recruiting
5
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
6
Orthopedic Centers of Colorado
Parker, Colorado, United States, 80134
Actively Recruiting
7
Steamboat Orthopaedic and Spine Institute
Steamboat Springs, Colorado, United States, 80487
Actively Recruiting
8
Curalta Clinical Trials
Westwood, New Jersey, United States, 07662
Actively Recruiting
9
Atrium Health Mercy
Charlotte, North Carolina, United States, 28207
Not Yet Recruiting
10
West Clinical Research
Morehead City, North Carolina, United States, 28557
Actively Recruiting
11
University of Cincinnati Department of Orthopaedic Surgery
Cincinnati, Ohio, United States, 45267
Actively Recruiting
12
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
13
Memorial Hermann Center
Houston, Texas, United States, 77043
Actively Recruiting
14
HD Research Corp.
Houston, Texas, United States, 77401
Actively Recruiting
15
Flourish Research San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
16
JBR Clinical Research
Salt Lake City, Utah, United States, 84107
Actively Recruiting
Research Team
A
Adrian Orr, VP Clinical Development
CONTACT
L
Luis Toro, Medical Monitor for IQVIA, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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