UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008171 |
|---|---|
| Receipt number | R000009584 |
| Scientific Title | Investigator initiated clinical study on the efficacy and safety of autologous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion in the knee |
| Date of disclosure of the study information | 2012/06/15 |
| Last modified on | 2016/12/16 16:00:47 |
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Basic information
Public title
Investigator initiated clinical study on the efficacy and safety of autologous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion in the knee
Acronym
Investigator initiated clinical study on the efficacy and safety of autologous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion in the knee
Scientific Title
Investigator initiated clinical study on the efficacy and safety of autologous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion in the knee
Scientific Title:Acronym
Investigator initiated clinical study on the efficacy and safety of autologous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion in the knee
Region
| Japan |
Condition
Condition
focal articular cartilage lesion in the knee
Classification by specialty
| Orthopedics | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect information for a well-designed clinical study pivotal in the future, to explore the effectiveness evaluation index and point at the same time and to confirm the safety of knee joint cartilage regeneration therapy by autologoous cultured chondrocyte processed product (IK-01) in patients with focal articular cartilage lesion (lesion of medial/lateral condyle, patellar and/or tibial articulation; including osteochondritis dissecans) in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
IKDC score: assessment of delta IKDC score at 52wks after operation compared with score at pre-operation
Key secondary outcomes
1.IKDC score: assessment of delta IKDC score at 4wks, 12wks, 24wks and 36wks after operation and discontinuation compared with score at pre-operation
2.Lysholm score, VAS: assessment of deltaIKDC score at 4wks, 12wks, 24wks, 36wks and 52wks after operation and/or discontinuation compared with score at pre-operation
3.Histological assessment of the site of transplantation of IK-01 (knee arthroscopy, knee X-ray, knee MRI, hardness of the articular cartilage tissue) :assessment of the status of site of transplantation at 2wks, 12wks, 24wks and 52wks after operation and/or discontinuation
X-ray image and hardness of the articular cartilage tissue measured by biosensor at operation of IK-01 transplantation in the knee, and MRI image at 2wks after operation are used as baseline , assessment of surface structure, congruity around tissue, mechanical strength of cartilage tissue and quality of reproduced cartilage tissue on the site of transplantation of IK-01 on each point are evaluated global (as X-ray image and MRI image as assessment at 12wks, 24wks, 52wks after operation and/or discontinuation, as hardness of the articular cartilage tissue as assessment at 52wks and/or discontinuation)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To transplant autologous cultured chondrocyte processed product (IK-01) for focal articular cartilage defects
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. patient more than 20 years and less than 50 years on obligation of the informed consent
2. patient obligated informed consent in written
3. patient with IKDC score < 60 in screening period
4. patient with focal articular cartilage lesions in the knee (including osteochondritis dissecans )
5.patient with III or IV in either ICRS or Outerbridge category.
6. patient with III or IV in nelson category by MRI image in the case of osteochondritis dissecans
7. patient with solid articular cartilage confirmed after debrided by knee arthroscopy in the case of the surface of articular cartilage lesion < 9 cm2
8. patient treated with existing standard therapy (ex; microfrature, mosaicplasty and so on) in the case of the surface of articular cartilage lesion < 4 cm2
Key exclusion criteria
1. patient with knee osteoarthritis (articluar cartilage changed denatuation)
2. patient with more than one site of arthropathia in lower extremity
3. patient with more than two sites of articular cartilage lesions, or focal cartilage lesions on both sides of kneejoints that need for treatment
4. patient with gout or pseudogout
5. patient with articular cartilage lesions in both articular surface and other side surface
6. patient with paralysis associated with neurological disease
7. patient need for bone transplantation from other site, for example, ilium (excluding removal of free bone fragment and irrigation of lesion site)
8. patient with a history of surgery or its need, for example of ablation or suturation of knee meniscus in injured side, but except in the presence of passed consistent term (8 wks over) after surgery of ablation or suturation of maximum partial knee meniscus of 1/3
9. patient with a history of surgery or its need, for example of ligament reconstruction of knee in diseased side, but except in the presence of passed consistent term (8 wks over) after surgery of ablation or suturation of knee meniscus
10. patient with a history of allergic reaction to collagen-containing products
11. patient with a history of serious hypersensitivity or anaphylactic shock to fibrin glue (Bolheal)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryosuke Kuroda, M.D., Ph.D |
Organization
Kobe University Hospital/ Foundation for Biomedical Research and Innovation Hospital
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, 650-0017 Japan/
TEL
0783825111
kuroda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Yamasaki |
Organization
Kobe University Hospital
Division name
Center for Clinical Reserch
Zip code
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, 650-0017 Japan
TEL
078-382-6667
Homepage URL
http://www.hosp.kobe-u.ac.jp/chiken/00chiken_top.html
junkoy@med.kobe-u.ac.jp
Sponsor or person
Institute
Ryosuke Kuroda, M.D., Ph.D
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神戸大学医学部附属病院（兵庫県）/
先端医療センター病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 05 | Month | 12 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 14 | Day |
Last modified on
| 2016 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009584
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