UMIN-CTR Clinical Trial

Basic information
Public title	New application of collagen membrane for less invasive procedure of autologous cultured cartilage implantation
Acronym	New application of collagen membrane for autologous cultured cartilage implantation
Scientific Title	New application of collagen membrane for less invasive procedure of autologous cultured cartilage implantation
Scientific Title:Acronym	New application of collagen membrane for autologous cultured cartilage implantation
Region	Japan

Condition
Condition	Full-thickness articular cartilage defects of the knee due to trauma or osteochondritis dissecans
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate safety and efficacy of collagen membrane for the autologous chondrocyte implantation (ACI) to eliminate periosteum harvest for less invasive procedure and to deliver more simple procedure.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical score from Knee Injury and Osteoarthritis Outcome Score (KOOS) sheet obtained at registration, 26 weeks, and 52 weeks after implantation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	JACC (autologous cultured cartilage) will be prepared by Japan Tissue Engineering Co., Ltd following established protocol and delivered to our hospital with certified quality. Patients will be admitted to the Hiroshima University Hospital with general manner and anesthetized at operation room (anesthesia method will be decided by anesthesiologist). Under anesthesia, a medial or lateral parapatellar arthrotomy will be carried out to approach lesions. The lesion will be debrided as far as normal surrounding cartilage and until healthy subchondral bone. The defect was covered by a sutured collagen membrane. The membrane was shaped and sutured to the surrounding rim of normal cartilage with interrupted 5-0 nylon and loosely tied 4-0 vicryl sutures. After suturing half of the border of the membrane, the JACC will be placed in the defect, and then remaining border of the membrane will be sutured. Pull-out suture will be applied if it will be required to cover JACC. The joint capsule, retinaculum, and skin were sutured in separate layers. The grafted site will be confirmed its stability during range of motion before wound closure.
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	13 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Over 13 year old 2. Diagnosed as chondral lesion due to trauma or osteochondritis dissecans of the knee 3. Lesion size is over 4cm2 4. Patients consented to being enrolled this study with specific form
Key exclusion criteria	1. Patient who is diagnosed as oteoarthritis of the knee 2. Patient who is diagnosed or suspected malignant tumor 3. Patient who has complications and considered as inappropriate case by orthopaedic surgeon in charge. 4. Hypersensitive patients against gentamicin, amphotericin B, or amnoglycoside. 5. Hypersensitive patients against intradermal injection of atelocollagen or bovine product. 6. Patient who has allergic reaction to bovine or swine. 7. Patient who is diagnosed as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, autoimmune thyropathy, multiple arteritis, scleroderma, ulcerative colitis, Crohn's disease, Sjogren's syndrome, Reiter's syndrome, mixed connective tissue dissase. 8. Patient who has past history about anaphylactic shock. 9. Patient who has hypersensitive against atelocollagen. 10. Patient who is considered as inappropriate case by orthopaedic surgeon in charge.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuo Adachi
Organization	Hiroshima University Hospital
Division name	Department of Orthopaedic Surgery
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5230
Email	nadachi@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masakazu Ishikawa
Organization	Hiroshima University Hospital
Division name	Department of Orthopaedic Surgery
Zip code
Address	1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL	082-257-5233
Homepage URL
Email	mishikawa@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital
Institute
Department

Funding Source
Organization	Japan Tissue Engineering Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2017 Year 06 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
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	Terminated
Date of protocol fixation	2017 Year 05 Month 10 Day
Date of IRB	2017 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 05 Month 25 Day
Last modified on	2019 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031492