UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033510 |
|---|---|
| Receipt number | R000038213 |
| Scientific Title | clinical results of adipose-derived regenerative cell therapy for osteoarthritis |
| Date of disclosure of the study information | 2018/07/25 |
| Last modified on | 2021/07/27 09:05:35 |
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Basic information
Public title
clinical results of adipose-derived regenerative cell therapy for osteoarthritis
Acronym
ADRC for OA
Scientific Title
clinical results of adipose-derived regenerative cell therapy for osteoarthritis
Scientific Title:Acronym
ADRC for OA
Region
| Japan |
Condition
Condition
osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check the safety and efficacy of adipose-derived regenerative cell therapy for osteoarthritis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JKOOS score
Key secondary outcomes
clinical course, VAS, radiological evaluation, adverse effect, cytokines of blood and joint fluid
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Informed consent is obtained
patients who are more than 20 years old
Diagnosed with osteoarthritis
Kellgren-Lawrence's X-ray classification grade 2 or more
resistanct for conservative therapy for more than 3 months,
ASA-PS (American Society of Anesthesiologists physical status) classifies 1 or 2
Enough amount of fat 100mL or more
White blood cells > 2,000/mm3
Hemoglobin >8.0g/dL
Platelet > 150,000/mm3
AST (GOT) and ALT (GPT) <100 U/L
T-bil < 1.5mg/dL
CCr 30mL/min or more
Key exclusion criteria
Patients with artificial joint replacement
Sever condition such as heart disease, kidney disease, respiratory disease or blood disease
Patients with malignancy
Anti-cancer drug, immunosuppression medicine, steroid administration
HIV-infected patients, active infections
Not appropriate as a physician's judgement
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Hayashi |
Organization
Kanazawa Univ
Division name
orthopaedic surgery
Zip code
Address
Takaramachi 13-1, Kanazawa
TEL
0762652374
khayashi830@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Hayashi |
Organization
Kanazawa University
Division name
orthopaedic surgery
Zip code
Address
Takaramachi 13-1, Kanazawa
TEL
0762652374
Homepage URL
khayashi830@gmail.com
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Univ
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagayaki clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 07 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
clinical course, VAS, radiological evaluation, adverse effect, cytokines of blood and joint fluid
Management information
Registered date
| 2018 | Year | 07 | Month | 25 | Day |
Last modified on
| 2021 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038213
