UMIN-CTR Clinical Trial

Basic information
Public title	The clinical study for the joint treatment by allogeneic cell sheet
Acronym	The clinical study for the joint treatment by allogeneic cell sheet
Scientific Title	The clinical study for the joint treatment by allogeneic cell sheet
Scientific Title:Acronym	The clinical study for the joint treatment by allogeneic cell sheet
Region	Japan

Condition
Condition	Cartilage defects associated with osteoarthritis of the knee
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Chondrocytes isolated from samples obtained at polydactyly surgery are passaged in culture as allogeneic cells and then cryopreserved. From the cryopreserved samples, cells which have been verified for safety and property checked as chondrocyte sheet are cultured and fabricated into an allogeneic chondrocyte sheet. The sheet is then transplanted into patient with cartilage defect of the knee joint, and cartilage regeneration is evaluated. We provide objective evaluations of the safety of this new treatment as a primary endpoint.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Frequency and content of adverse events.
Key secondary outcomes	Clinical evaluation, X-ray, MRl, Arthroscopy, Photoacoustic evaluation, and Pathological evaluation.

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	Chondrocytes isolated from samples obtained at polydactyly surgery are passaged in culture as allogeneic cells and then cryopreserved. From the cryopreserved samples, cells which have been verified for safety and property checked as chondrocyte sheet are cultured and fabricated into an allogeneic chondrocyte sheet. The sheet is then transplanted into patient with cartilage defect of the knee joint.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	Cartilage defects under arthroscopy must be greater than or equal to Outerbridge classification Grade III. In addition, the patellofemoral joint and/or the condyle of the femur must have a cartilage defect or defects which can be fully covered by allogeneic chondrocyte sheets and which have traditionally been indicated for marrow stimulation techniques or osteochondral autografts.
Key exclusion criteria	1. Obtaining informed consent from the patient is difficult. 2. Having complications hindering surgery under general anesthesia or complications affecting knee surgery. 3. Having problematic infectious disease (including positive of HBV, HCV, HIV, HTLV, FTA-ABS.) 4. Having rheumatoid arthritis or other systemic inflammatory disease.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Sato
Organization	Tokai University School of Medicine
Division name	Surgical Science, Department of Orthopaedic Surgery
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Email	sato-m@is.icc.u-tokai.ac.jp

Public contact
Name of contact person	1st name Masato Middle name Last name Sato
Organization	Tokai University School of Medicine
Division name	Surgical Science, Department of Orthopaedic Surgery
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Homepage URL
Email	sato-m@is.icc.u-tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokai university certified committee for regenerative medicine
Address	143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan
Tel	0463-93-1121
Email	watanabe@tsc.u-tokai.ac.jp

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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 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	10
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	2014 Year 05 Month 19 Day
Date of IRB	2016 Year 03 Month 11 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 19 Day
Last modified on	2022 Year 03 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017322