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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035151
Receipt No. R000039049
Scientific Title Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Date of disclosure of the study information 2018/12/10
Last modified on 2019/02/14

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Basic information
Public title Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Acronym Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Scientific Title Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Scientific Title:Acronym Clinical study of minimally invasive transplantation of autologous chondrocytes products (ACP) for cartilage repair for the knee joint
Region
Japan

Condition
Condition Focal cartilage defect of the knee joint caused by trauma and/or early osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the safety and study evaluation criteria for a focal cartilage defect repair of the knee joint caused by trauma and/or early osteoarthritis using minimally invasive transplantation of autologous chondrocytes products (ACP).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Clinical evaluation (Improvement of KOOS (Knee injury and Osteoarthritis Outcome Score) from baseline)
Key secondary outcomes Clinical evaluation, MRl, Arthroscopy, Pathological evaluation and Activity evaluation. Frequency and content of adverse events.

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 are obtained from unloaded part of patient's cartilage and cultured through passaging. The chondrocytes mixed with hydrogel are transplanted under arthroscopy or minimal open surgery.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with symptomatic pain of the knee who has focal chondral defect detectable by MRI.
Patients with chondral defect of ICRS III/IV or Outerbridge-Brittberg III/IV.
The size of chondral defect:2-9cm2.
Key exclusion criteria Patients with
1.advanced osteoarthritis KL grade II and above with narrowing of the gap of knee joint,
2.arthritis with autoimmune disease such as Rheumatoid arthritis,
3.abnormal alignment of lower extremity,
4.infectious disease (HIV/HBV/HCV/HTLV etc.).
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Nakata
Organization Osaka University Graduate School of Medicine
Division name Medicine for Sports and Performing Arts
Zip code
Address 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6210-8439
Email ken-nakata@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kanamoto
Organization Osaka University Graduate School of Medicine
Division name Medicine for Sports and Performing Arts
Zip code
Address 2-2 Yamada-oka, Suita, Osaka, 565-0871, Japan
TEL 06-6210-8439
Homepage URL
Email takanamoto@hss.osaka-u.ac.jp

Sponsor
Institute Department of Orthopaedics, Osaka University
Graduate School of Medicine
Institute
Department

Funding Source
Organization OLYMPUS-RMS CORP.
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
2018 Year 12 Month 10 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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 06 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039049

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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