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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034801
Receipt No. R000039592
Official scientific title of the study Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis
Date of disclosure of the study information 2018/11/07
Last modified on 2018/11/07

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Basic information
Official scientific title of the study Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis
Title of the study (Brief title) Multicenter, parallel-group clinical trial of autologous cultured cartilage ACC-01 compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis
Region
Japan

Condition
Condition Knee osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the efficacy and safety of autologous cultured cartilage ACC-01 by multicenter, parallel-group clinical trial compared with intra-articular injection of sodium hyaluronate in patients with knee osteoarthritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Change in WOMAC score before and after treatment with the investigational products
Key secondary outcomes Efficacy
1) Change in WOMAC subscale score (pain, stiffness, physical Function) before and after treatment with the investigational products
2) Change in Lysholm Knee Score (LKS) before and after treatment with the investigational products
3) MRI_T2 values
4) 3D MOCART score (MRI evaluation)
5) ICRS score *1 (arthroscopy)
6) Histological evaluation *2
7) Number of doses of NSAIDs
8) Presence or absence of restoration with hyaline cartilage-like tissue
*1 Patients who give separately written informed consent of arthroscopy
*2 Patients who give separately written informed consent of biopsy

Safety
1) Number and rate of adverse events and product-related adverse events
2) Number and rate of significant product-related adverse events
3) Product problems

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ・Taking healthy cartilage tissue
・Transplantation of autologous cultured cartilage ACC-01
Interventions/Control_2 Intra-articular injection of sodium hyaluronate
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients who are aged 20 years or older on the acquisition date of informed consent before clinical study, and who can give a written informed consent
2) Patients who have localized cartilage defect lesion size over 2 cm2
3) Patients diagnosed as osteoarthritis (Kellgren-Lawrence grade 2 or grade 3) by x-ray examination
4) Patients with knee pain
5) Patients who were treated by conservative therapy, including exercise therapy, in the last 3 months
Key exclusion criteria 1) Patients who participated in previous clinical trials of ACC-01, or patients who have undergone ACC-01 transplantation
2) Patients who are aged 75 years or older on the acquisition date of informed consent before clinical study
3) Patients with BMI >= 30
4) Patients who have difficulty in fixation by periosteum because of entire cartilage defects in the knee joint
5) Patients with severe knee deformation (FTA >=180 degrees, <=170 degrees)
6) Patients who underwent surgery or arthroscopy in the affected knee joint in the last 3 months
7) Patients with a meniscal tear requiring treatment in the affected knee joint, or patients who underwent surgical treatment to meniscal in the affected knee joint in the last 3 months
8) Patients with autoimmune disease (e.g., rheumatoid arthritis), or patients with a history of these diseases
9) Patients with or suspected of having a malignancy or patients with a history of malignancy less than 5 years
10) Patients who have complications in the affected knee joint or whole body and judged that a doctor had difficulty with an evaluation
11) Patients with hypersensitivity to antibiotics (gentamicin or amphotericin B), or patients with a history of hypersensitivity to aminoglycoside antibiotic
12) Patients who have allergic reaction to bovine or swine
13) Diabetic patients who have poorly blood sugar control
14) Patients with a history of anaphylactic reaction
15) Patients with a history of hypersensitive against atelocollagen
16) Patients who cannot have an MRI examination
17) Patients who are participating in other clinical trials on the acquisition date of informed consent before this clinical study and patient who is planning to participate in other clinical studies while participating in this clinical study
18) Pregnant women, lactating women and patients who may be pregnant, or patients who desire pregnancy during clinical studies
19) Patients for whom doctors decide as not appropriate to participate in this clinical study
Target sample size 58

Research contact person
Name of lead principal investigator Shigeaki Hayashi
Organization Japan Tissue Engineering Co., Ltd.
Division name Clinical Development Dept.
Address 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL 0533-66-2020
Email shigeaki_hayashi@jpte.co.jp

Public contact
Name of contact person Shigeaki Hayashi
Organization Japan Tissue Engineering Co., Ltd.
Division name Clinical Development Dept.
Address 6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL 0533-66-2020
Homepage URL
Email shigeaki_hayashi@jpte.co.jp

Sponsor
Institute Japan Tissue Engineering Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 27 Day
Anticipated trial start date
2019 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039592

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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