Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect

NCT01626677 | Completed Phase 3 DMC

• 1 other identifier: CARTISTEM_CR_F/U
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 10

Brief Summary

This is a long term follow-up study to investigate the safety and efficacy of CARTISTEM®, human umbilical cord blood-derived mesenchymal stem cells, in repair of cartilage injury or defects, compared with microfracture. Subjects who participated in and completed the Phase III trial (NCT01041001) will be tracked until the 60 month post-treatment timepoint.

Conditions

Degenerative Osteoarthritis; Defect of Articular Cartilage

Keywords

Umbilical Cord Blood; Mesenchymal Stem Cells; Cartilage injury; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Degree of improvement in knee assessments compared to the active control (microfracture)

  Knee assessments will be performed using the following tools: * IKDC (International Knee Documentation Committee) * Pain score on VAS (Visual Analogue Scale) * WOMAC (Western Ontario and McMaster Universities Arthritis Index)

  36 months, 48 months, and 60 months

Secondary Outcomes (1)

• Number of subjects with adverse events

  36 months, 48 months, and 60 months

Study Arms (2)

CARTISTEM

EXPERIMENTAL

A single dose of 500㎕/㎠ of cartilage defect

Biological: CARTISTEM

Microfracture

ACTIVE COMPARATOR

conventional treatment method

Procedure: Microfracture

Interventions

CARTISTEM BIOLOGICAL

A single dose of 500㎕/㎠ of cartilage defect

Also known as: hUCB-MSCs

CARTISTEM

Microfracture PROCEDURE

Active control

Also known as: Conventional surgical treatment

Microfracture

Eligibility Criteria

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

You may qualify if:

• Patients with knee joint cartilage defect or injury of ICRS (International Cartilage Repair Society) Grade 4 confirmed by arthroscopy (At screening, patients diagnosed as such with an MRI may be included)
• Male or female patients at least 18 years of age
• Patients whose lesion (unilateral joint) is 2 ㎠ \~ 9㎠ in size
• Patients with articular swelling, tenderness and active range of motion of Grade 2 or below
• Patients with pain in affected joint of 60-mm or below on a 100-mm VAS (visual analogue scale)
• Patients with adequate blood coagulation activity: PT(INR) \< 1.5, APTT \<1.5×control
• Patients with adequate renal function: Creatinine ≤ 2.0 ㎎/㎗, levels of proteinuria measured with Dipstick: trace or less
• Patients with adequate hepatic function: Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
• Patients who have received no surgery or radiation therapy in the affected joint within the past 6 six weeks, and have recovered from the side effects of such past treatments
• Female patients of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study
• Patients whose physical examination results show no ligament instability of Grade II or above (Grade 0: none, Grade I: 0-5 mm, Grade II: 5-10 mm, Grade III: \>10 mm)
• Patients who voluntarily agreed to enroll in the study and signed an informed consent form

You may not qualify if:

• Patients with autoimmune disease or the medical history
• Patients with infections requiring parenteral administration of antibiotics
• Patients with myocardial infarction, ischemic heart failure, other serious heart conditions or uncontrolled hypertension, or any medical history of such diseases
• Patients with serious internal diseases
• Patients who are currently pregnant or nursing
• Patients with psychotic diseases, epilepsy, or any history of such diseases
• Patients with alcohol abuse
• Patients who smoke excessively
• Patients with chronic inflammatory articular diseases such as rheumatoid arthritis
• Patients who were enrolled in any other clinical trials within the past four weeks
• Patients who had been administered with immunosuppressants such as Cyclosporin A or azathioprine within the past six weeks
• Patients whose physical examination results show ligament instability of Grade II or above (Grade 0: none, Grade I: 0-5 mm, Grade II: 5-10 mm, Grade III: \>10 mm)
• Patients with a known history of hypersensitivity/allergy to gentamicin
• Patients whom the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above

Sponsors & Collaborators

• Medipost Co Ltd.: lead
• Dong-A Pharmaceutical Co., Ltd.: collaborator

Study Sites (10)

Inha University Hospital

Incheon, 400-711, South Korea

Location

Gachon University Gil Hospital

Incheon, 405-760, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Hanyang University Medical Center

Seoul, 133-792, South Korea

Location

Seoul Veterans Hospital

Seoul, 134-060, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea University Guro Hospital

Seoul, 152-703, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

Related Publications (1)

• Lim HC, Park YB, Ha CW, Cole BJ, Lee BK, Jeong HJ, Kim MK, Bin SI, Choi CH, Choi CH, Yoo JD; Cartistem Research Group; Yoon JR, Chung JY. Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cell Implantation Versus Microfracture for Large, Full-Thickness Cartilage Defects in Older Patients: A Multicenter Randomized Clinical Trial and Extended 5-Year Clinical Follow-up. Orthop J Sports Med. 2021 Jan 12;9(1):2325967120973052. doi: 10.1177/2325967120973052. eCollection 2021 Jan.

  PMID: 33490296 DERIVED

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

Joint Diseases; Osteoarthritis

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Hong-chul Lim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Beom-gu Lee, MD, PhD

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

• Jong-hyeok Choi, MD, PhD

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

• Hwa-jae Jeong, MD, PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

• Chul-won Ha, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Jung-ro Yoon, MD, PhD

  Seoul Veterans Hospital

  PRINCIPAL INVESTIGATOR

• Seong-il Bin, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Jae-doo Yoo, MD, PhD

  Ewha Womans Mokdong Hospital

  PRINCIPAL INVESTIGATOR

• Myung-ku Kim, MD, PhD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Choong-hyuk Choi, MD, PhD

  Hanyang University

  PRINCIPAL INVESTIGATOR

• Young-Chul Yoon, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 25, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

KR (10)