Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects

NCT01733186 | Completed Phase 1 Results DMC

• 1 other identifier: MP-0201-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is safe and effective in the treatment of articular cartilage defects of the knee as a result of ageing, trauma, or degenerative diseases.

Conditions

Degeneration Articular Cartilage Knee

Keywords

human umbilical cord blood-derived mesenchymal stem cells; MSC; cartilage lesion; cartilage defect; degenerative arthritis; stem cell implantation

Outcome Measures

Primary Outcomes (1)

• IKDC Score

  Subjects underwent a self-assessment of knee function using the IKDC (International Knee Documentation Committee Assessment)subjective knee evaluation before and after the administration of the IP. The assessment is designed to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. The possible score ranges from 0 to 100, where 100 = no limitation with daily or sporting activities and the absence of symptoms. The IKDC assessment was performed before IP administration and at Months 12 after IP administration in an exploratory fashion. The IKDC score from the Month 12 visit was used as a primary indicator of the post operative change. The outcome was presented with the post-operative change amount from the baseline.

  12 months

Secondary Outcomes (4)

• VAS

  24 months

• Lysholm Score

  24 months

• KOOS Score

  24 months

• IKDC Score

  24 months

Study Arms (1)

CARTISTEM®

EXPERIMENTAL

Drug name and ingredients: CARTISTEM \[allogeneic-unrelated, umbilical cord blood-derived mesenchymal stem cells, ex vivo cultured, combined with sodium hyaluronate\] Dosage: Administer 0.5 mL of the combination product per cm\^2 of the cartilage defect

Biological: CARTISTEM®

Interventions

CARTISTEM® BIOLOGICAL

Also known as: human umbilical cord blood-derived mesenchymal stem cells

CARTISTEM®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an intended- to- treat single focal, full-thickness cartilage defect (ICRS \[International Cartilage Repair Society\] Grade 3 or 4) of the knee as a result of ageing, trauma, or degenerative diseases.
• Age ≥ 18 years old
• Size of the articular cartilage lesion is ≥ 2 cm2
• Swelling, tenderness and active range of motion ≤ Grade II
• Joint pain : 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening
• Appropriate blood coagulation, kidney and liver function laboratory parameters: PT(INR) \< 1.5, APTT \<1.5×control Creatinine ≤ 2.0 mg/dL Albumin ≤ trace in urine dipstick test Bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 100 IU/L
• Ligament instability ≤ Grade II
• Lower extremity alignment within 5 degrees of the neutral weight bearing axis
• No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining
• Ability and willingness to fully participate in the post-operative rehabilitation program
• Subject is informed of the investigational nature of this study, voluntarily agrees to participate in the study, and signs an IRBapproved informed consent prior to performing any of the screening procedures
• Body Mass Index (BMI) ≤ 35 kg/m2

You may not qualify if:

• Patients who have been treated previously and are asymptomatic
• Avascular necrosis/ osteonecrosis
• Autoimmune or inflammatory joint disease
• History of infection within the past 6 weeks
• Surgery or radiation therapy within the past 6 weeks
• Serious medical co-morbidities, which would otherwise contraindicate surgery, as determined by the investigator
• Currently pregnant or nursing
• Psychotic diseases, epilepsy, or any history of such diseases
• Current abuse of alcohol (\> 10 drinks weekly) and/or regular exposure to other substances of abuse, currently an active smoker
• Chronic inflammatory articular diseases such as rheumatoid arthritis
• Enrolled in any other clinical trials within the past 4 weeks
• Administered immunosuppressants such as Cyclosporin A or azathioprine within the past 6 weeks
• Ligament instability \> Grade II
• Uncorrected significant lower extremity malalignment (i.e. \> 5 degrees)
• (sub-) Total meniscectomy (\<5mm rim remaining)

Sponsors & Collaborators

• Medipost, Inc.: lead

Study Sites (2)

Cartilage Restoration Center; RUSH University Medical Center

Chicago, Illinois, 60612, United States

Location

Cartilage Repair Center; Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Related Links

• Study to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Director of Product Development Department
• Organization: MEDIPOST Co., Ltd.

meehyunj@medi-post.co.kr

+82-2-3465-6740

Study Officials

• Brian J Cole, MD

  Cartilage Restoration Center, Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Andreas H Gomoll, MD

  Cartilage Repair Center, Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 26, 2012
• Study Start: January 7, 2013
• Primary Completion: June 2, 2017
• Study Completion: August 29, 2017
• Last Updated: January 29, 2026
• Results First Posted: July 30, 2021

Record last verified: 2026-01

Locations

US (2)