Cartistem®治疗膝关节软骨损伤和微骨折的有效性和安全性研究
2012-01-20 00:54:00   来源：   

Study to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect
The recruitment status of this study is unknown because the information has not been verified recently.
Verified on December 2009 by Medipost Co Ltd..   Recruitment status was  Recruiting

First Received on December 29, 2009. No Changes Posted
Sponsor:  Medipost Co Ltd.
Information provided by:  Medipost Co Ltd.
ClinicalTrials.gov Identifier:  NCT01041001
   Purpose
The purpose of the study is to assess and compare the safety and efficacy of the allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product (Cartistem®) to that of a microfracture treatment in patients with articular cartilage defect or injury.


Condition
Intervention
Phase

Cartilage Injury
Osteoarthritis Biological: Cartistem
Procedure: Microfracture treatment Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Open-Label, Multi-Center and Phase 3 Clinical Trial to Compare the Efficacy and Safety of Cartistem® and Microfracture in Patients With Knee Articular Cartilage Injury or Defect

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Medipost Co Ltd.:

Primary Outcome Measures:
• ICRS Cartilage Repair Assessment will follow to determine the appropriate grade. The treatment will be considered efficacious if the ICRS grade drops by at least 1 grade or more from baseline to week 48. [ Time Frame: Week 0 and 48 ] [ Designated as safety issue: No ]


Secondary Outcome Measures:
• Degree of improvement in the grade of joint pain measured on a 100-mm VAS (Visual Analogue Scale) [ Time Frame: Week 0, 2, 4, 8, 12, 24, 36 and 48 ] [ Designated as safety issue: Yes ]
• Grade of cartilage regeneration in patients who agreed to a biopsy during arthroscopy at week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
• Changes in WOMAC scores [ Time Frame: Week 0, 2,4,8,12,24,36 and 48 ] [ Designated as safety issue: No ]
• Changes in IKDC Subjective Score [ Time Frame: Week 0, 2, 4, 8, 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
• ICRS scores [ Time Frame: Week 48 ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: February 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms
Assigned Interventions

Cartistem: Experimental
A single dose of 500㎕/㎠ of cartilage defect
Intervention: Biological: Cartistem Biological: Cartistem
allogeneic-unrelated umbilical cord blood-derived mesenchymal stem cell product
Microfracture treatment: Active Comparator
Intervention: Procedure: Microfracture treatment Procedure: Microfracture treatment

Detailed Description:
The cartilage is a unique avascular, aneural tissue that does not regenerate easily once damaged. Chondral defects or damages to articular cartilages due to accidents, necrosis of subchondral bone tissue, or arthritis have become some of the more common disorders today. About 15% of the world's population is reportedly suffering from cartilage and joint damages such as degenerative arthritis and rheumatoid arthritis. As population aging progresses and as more young people start taking up active sports, the size of the target patient group is also growing. However, despite ongoing research, an effective treatment for cartilage defects is yet to be discovered. Various different types of treatments are currently in use, such as drug therapy, arthroscopy, and artificial joint surgery. However, they all fail to address the root cause. Complete treatment, or regeneration of damaged or defective cartilage is impossible and continuous drug administration or secondary surgeries are required in many cases.
As a way of regenerating the damaged or defective cartilage tissue, treatment of localized damage to articular cartilage using autologous chondrocytes is currently under review. A few life science companies both home and abroad are marketing this method of treatment called 'autologous chondrocyte transplant'. The treatment involves the extraction of healthy cartilage tissue from the patient which is then cultured and transplanted into the damaged site.
However, this treatment requires the extraction of chondrocytes directly from the patient and thus causes trauma in healthy articular cartilage. Also, this type of treatment cannot be applied to large lesions, nor is the efficacy satisfactory in patients over the age of 40 whose cellular activation levels are low. Thus, autologous chondrocyte transplant is rather limited in the number of cells harvested and their activation level and is therefore restricted in terms of treatment site, severity of the condition, and the size of lesion. The current technology allows the application of treatments in local cartilage defects but not in degenerative arthritis or rheumatoid arthritis. The technology needs to be taken up to another level in order to benefit such prevalent arthritic disorders. Treatments using stem cells do not cause damage to healthy articular cartilage as they don't require the harvesting of healthy cartilage tissues from the patients. Moreover, the number of successfully cultured cells is larger due to the excellent proliferation capability of stem cells and thus, mass supply is possible.
This clinical trial for the stem cell therapies is essential because treatment of cartilage defects with umbilical cord blood-derived mesenchymal stem cells, known to have the highest level of activity among all adult stem cells, opens the possibility of articular cartilage regeneration even for aged patients and patients with large lesions unable to benefit from existing treatments.
The biggest challenge faced by nations competing in the field of "tissue differentiation and regeneration using stem cells" is the question of whether or not the use of embryonic stem cells is ethical. Chondrogenesis using umbilical cord blood-derived mesenchymal stem cells can not only avoid similar challenges, but also present an innovative treatment mode with significant clinical implications for the patients.
In the clinical study, mesenchymal stem cells will be isolated from umbilical cord blood and cultured, mixed with semi- solid polymer, and administered into the cartilage tissue lesion by orthopedic surgery in order to stimulate the regeneration of defective cartilage tissue and to improve their functions.
   Eligibility
Ages Eligible for Study:    18 Years and older
Genders Eligible for Study:    Both
Accepts Healthy Volunteers:    No
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 who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
   Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041001


Contacts
Contact: Wonil Oh, MD, PhD 82-2-3465-6677 [email]wioh@medi-post.co.kr[/email]

Contact: Young Jin Heo, MS 82-2-866-7141 [email]hyj@medi-post.co.kr[/email]



Locations
Korea, Republic of
Gachon University Gil Hospital Recruiting
Incheon, Gyunggido, Korea, Republic of, 405-760
Contact: Beom-gu Lee, MD     82-32-460-8411     [email]bklee@gilhospital.com[/email]    

Principal Investigator: Beom-gu Lee, MD            
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 400-711
Contact: Myung-ku Kim, MD,     82-32-890-3662     [email]m9kim@inha.ac.kr[/email]    

Principal Investigator: Myung-ku Kim, MD            
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seong-il Bin, MD     82-2-3010-3528     [email]sibin@amc.seoul.kr[/email]    

Principal Investigator: Seong-il Bin, MD            
Seoul Veterans Hospital Recruiting
Seoul, Korea, Republic of, 134-060
Contact: Jung-ro Yoon, MD     82-2-2225-1351     [email]zenyjr@yahoo.co.kr[/email]    

Principal Investigator: Jung-ro Yoon, MD            
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 158-710
Contact: Jae-doo Yoo, MD     82-2-2650-6142     [email]yjdos@ehwa.ac.kr[/email]    

Principal Investigator: Jae-doo Yoo, MD            
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Chul-won Ha, MD, PhD     82-2-3410-0275     [email]hacw@skku.edu[/email]    

Principal Investigator: Chul-won Ha, MD, PhD            
Hanyang University Medical Center Recruiting
Seoul, Korea, Republic of, 133-792
Contact: Choong-hyeok Choi, MD     82-2-2290-8483     [email]chhchoi@hanyang.ac.kr[/email]    

Principal Investigator: Choong-hyeok Choi, MD            
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Contact: Hong-chul Lim, MD     82-2-2626-3084     [email]lhc2455@korea.ac.kr[/email]    

Contact: Ji Hoon Bae, MD     82-2-2626-3084     [email]osman@korea.ac.kr[/email]    

Principal Investigator: Hong-chul Lim, MD            
Sub-Investigator: Ji Hoon Bae, MD            
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
Principal Investigator: Hong-chul Lim, MD, PhD Korea University Guro Hospital
   More Information

No publications provided
Responsible Party: Wonil Oh / Vice President, MEDIPOST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01041001     History of Changes

Other Study ID Numbers: MP-CRP-005
Study First Received: December 29, 2009
Last Updated: December 29, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Medipost Co Ltd.:
Umbilical Cord Blood
Mesenchymal Stem Cells
cartilage injury
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 18, 2012