Clinical trial NCT01626677: Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect
Official title: Long Term Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Degenerative Osteoarthritis
Defect of Articular Cartilage
Keywords: Umbilical Cord Blood
Mesenchymal Stem Cells
Cartilage injury
Osteoarthritis
Lead sponsor: Medipost Co Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Dong-A Pharmaceutical Co., Ltd.
First posted: 2012-06-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This long term follow-up study is performed to assess the long-term 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 were either administered CARTISTEM or treated with conventional microfracture in the primary phase III study (NCT01041001), will be further observed using various subjective knee assessments and MRI T2 mapping until the 60 month post-treatment timepoint.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Degree of improvement in knee assessments compared to the active control (microfracture)
timeFrame: 36 months, 48 months, and 60 months
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 36 months, 48 months, and 60 months
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Veterans Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Hong-chul Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: Beom-gu Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gangnam Severance Hospital
name: Jong-hyeok Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangbuk Samsung Hospital
name: Hwa-jae Jeong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Chul-won Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Veterans Hospital
name: Jung-ro Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Seong-il Bin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans Mokdong Hospital
name: Jae-doo Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Myung-ku Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Choong-hyuk Choi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Young-Chul Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.