UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Ryosuke Kuroda, M.D., Ph.D
Organization	Kobe University Hospital/ Foundation for Biomedical Research and Innovation Hospital
Division name	Department of Orthopaedic Surgery
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	Junko Yamasaki
Organization	Kobe University Hospital
Division name	Center for Clinical Reserch
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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