UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040885 |
|---|---|
| Receipt number | R000046638 |
| Scientific Title | Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee |
| Date of disclosure of the study information | 2020/06/26 |
| Last modified on | 2021/08/05 13:42:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase II Exploratory Study of Human (Allogeneic) Umbilical Cord Blood-Derived Mesenchymal Stem Cells for Osteoarthritis of the Knee
Acronym
A study for patients with osteoarthritis of the knee
Scientific Title
Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee
Scientific Title:Acronym
Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee
Region
| Japan |
Condition
Condition
osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to explore the efficacy and safety, and also extent of cartilage repair for patients with a confirmed diagnosis of osteoarthritis of the knee between the group of high tibial osteotomy (HTO) combined with transplantation of EVA-001, a human umbilical cord blood-derived mesenchymal stem cell product, and the group of high tibial osteotomy (HTO) alone
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of improvement in ICRS grade 1 or better at 52 weeks after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Study group: EVA-001 implantation/HTO combination group
Interventions/Control_2
Control group: HTO monoperative group
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be eligible
1)Men and women between the ages of 20 and 80 years
2)Patients with ICRS Grade 3 or 4 cartilage damage or deficiency in the knee joint as determined by magnetic resonance imaging (MRI) during the screening phase or by examination within the past 3 months.
3)Patients with a K and L Grade of 2 to 4 based on simple x-ray examination
4)Patients with an area of lesion damage of 2-9 cm2 that is the primary source of clinical symptoms
5)Patients with knee flexion contractures of 10 degrees or less
6)Patients who are eligible for high tibial osteotomy with a lateral knee angle (FTA:Femoro-tibial angle) of 180 to 185 degrees.
7)Patients with pain of 40 mm or more on the 100 mm VAS Scale
8)Patients with a BMI of 35 kg/m2 or less
9)Patients who do not wish to become pregnant during the trial period
10)Patients who have voluntarily decided to participate in the trial and have signed the consent form.
Key exclusion criteria
Patients who meet any of the following criteria shall be excluded
1)no remaining lateral cartilage due to progressive osteoarthritis of the knee 2) autoimmune diseases or a history of such diseases 3)an infection or suspected infection requiring parenteral antibiotics 4)serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease 5)gout or suspected gout 6)blood clotting abnormalities 7)serious renal function abnormalities 8)serious liver damage 9)serious medical conditions
10)malignancy or suspected malignancy 11)who are pregnant or potentially pregnant 12)who are currently breastfeeding 13)mental disorders or a history of mental disorders 14)who are habitual drinkers and are dependent or suspected of being alcoholic 15)who are nicotine dependent or suspected to be so 16)chronic inflammatory joint diseases 17)who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks 18)ligament fiber damage of Grade II or greater 19)paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect 20)a history of serious hypersensitivity to bovine-derived or porcine derived ingredients of this product 21)a history of severe hypersensitivity or anaphylactic shock to gentamicin 22)a history of severe hypersensitivity or anaphylactic shock to metal allergy 23)a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronic acid 24)a history of blood transfusion or transplantation 25)who have participated in another clinical trial within the past 3 months 26)who have been at rest for a long period of time within the past 3 months 27)a history of contraindications to MRI or contrast media 28)meniscus locking symptoms 29) Other patients who are determined to be unsuitable by the investigator or sub-investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Yamamoto |
Organization
EVASTEM Co., Ltd.
Division name
President & CEO
Zip code
1080071
Address
Shirokanedai ST bldg. 7F, 4-7-4 Shirokanedai Minato-ku Tokyo
TEL
0354226273
masao.yamamoto@evastem.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Yamamoto |
Organization
EVASTEM Co., Ltd.
Division name
President & CEO
Zip code
1080071
Address
Shirokanedai ST bldg. 7F, 4-7-4 Shirokanedai Minato-ku Tokyo
TEL
0354226273
Homepage URL
masao.yamamoto@evastem.jp
Sponsor or person
Institute
EVASTEM Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital
Address
38 Morohongo, Iruma-gun Moroyamamachi, Saitama
Tel
049-276-1454
tikens@saitama-med.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
| 2020 | Year | 06 | Month | 26 | 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
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
jRCT2033210138
Management information
Registered date
| 2020 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046638
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
