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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008171
Receipt No. 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

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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
Email 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
Email junkoy@med.kobe-u.ac.jp

Sponsor
Institute Ryosuke Kuroda, M.D., Ph.D
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009584

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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