UMIN-CTR Clinical Trial

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
Email	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
Email	masao.yamamoto@evastem.jp

Sponsor
Institute	EVASTEM Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046638