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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026732
Receipt No. R000029967
Scientific Title Intraarticular injections of synovial stem cells for osteoarthritis of the knee
Date of disclosure of the study information 2017/06/01
Last modified on 2019/07/08

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Basic information
Public title Intraarticular injections of synovial stem cells for osteoarthritis of the knee
Acronym Intraarticular injections of synovial stem cells for osteoarthritis of the knee
Scientific Title Intraarticular injections of synovial stem cells for osteoarthritis of the knee
Scientific Title:Acronym Intraarticular injections of synovial stem cells for osteoarthritis of the knee
Region
Japan

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

Objectives
Narrative objectives1 To investigate the safety and efficacy of intraarticular injections of autologous synovial stem cells into the knee with osteoarthritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes 1) Safety
Adverse events and treatment-emergent adverse event
2) Efficacy
Change in cartilage area ratio calculated with MRI 3D analysis at 30 weeks after injection of stem cells from baseline
Key secondary outcomes Efficacy
Knee Injury and Osteoarthritis Outcome Score (KOOS), Lysholm score, numerical rating scale (NRS), X-ray examination, MRI 3D analysis (meniscal thickness, width, and area ratio)

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
Maneuver Other
Interventions/Control_1 Intraarticular injections of synovial stem cells
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
20 years-old <=
Age-upper limit

Not applicable
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 with knee pain
3) Patients diagnosed as osteoarthritis by x-ray examination
4) Patients in whom hyaluronic acid injections were not effective for pain relief
5) Patients in whom exercise therapy in these 3 months have not been effective for pain relief
Key exclusion criteria 1) Patients whose reduction of cartilage area ratio is not greater than 2% from week -30 to week -15
2) Patients who is unidentified
3) Patients who underwent surgery or arthroscopic examination in the affected knee
4) Patients whose clinical symptoms have been sufficiently improved by conservative treatments in the last 3 months
5) Patients with a catching sensation in the knee
6) Patients with knee instability
7) Patients with a history of trauma in the knee
8) Patients for whom MRI is not indicated because of claustrophobia and so on
9) Patients who have had any intraarticular injections (local anesthetic agent, corticosteroid agent, hyaluronic acid) or arthrocentesis in these 3 months
10) Patients with active infection
11) Patients diagnosed or suspected as malignant tumor in these 5 years
12) Patients sensitive to antibiotics (penicillin, streptomycin or amphotericin B)
13) Patients sensitive to animal (bovine) origin materials
14) Patients with poor controlled diabetes
15) Patients with a pacemaker
16) Patients with poor general condition
17) Patients with difficulties in self-determination because of dementia and so on
18) Pregnant women, lactating women and patient who may be pregnant, or patient who desires pregnancy during clinical study
19) Patient who participated in other clinical trials, patient participating in other clinical studies and patient planning to participate in other clinical studies while participating in this clinical study within 12 weeks before the start of transplantation of cellular product
20) Patients for whom doctors decide as not appropriate to participate in the clinical study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Sekiya
Organization Tokyo Medical and Dental University
Division name Center for Stem Cell and Regenerative Medicine
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-4017
Email sekiya.arm@tmd.ac.jp

Public contact
Name of contact person
1st name Office
Middle name
Last name Administrator
Organization Medical Hospital of Tokyo Medical and Dental University
Division name Clinical Research Center
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5612
Homepage URL http://www.tmd.ac.jp/medhospital/topics/
Email tiken.crc@tmd.ac.jp

Sponsor
Institute Medical Hospital of Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University Hospital of Medicine, Institutional Review Board
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5612
Email tiken.crc@tmd.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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 26 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
2017 Year 03 Month 28 Day
Last modified on
2019 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029967

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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