UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049726 |
|---|---|
| Receipt number | R000056641 |
| Scientific Title | Prospective observational study on pain relief, functional evaluation and safety of human adipose-derived mesenchymal stem cell culture supernatant solution for acute and chronic pain Singl-center, single-arm open study |
| Date of disclosure of the study information | 2022/12/08 |
| Last modified on | 2023/12/09 19:46:32 |
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Basic information
Public title
Prospective observational study on pain relief, functional evaluation and safety of human adipose-derived mesenchymal stem cell culture
supernatant solution for acute
and chronic pain Singl-center, single-arm open study
Acronym
MSC-CM Trial
Scientific Title
Prospective observational study on pain relief, functional evaluation and safety of human adipose-derived mesenchymal stem cell culture
supernatant solution for acute
and chronic pain Singl-center, single-arm open study
Scientific Title:Acronym
MSC-CM Trial
Region
| Japan |
Condition
Condition
Acute pain and Chronic pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the social and academic significance of MSC-CM as a useful treatment method by accumulating evidence as a safe and highly
effective treatment method by
verifying pain relief, functional
evaluation, and safety as a
prospective observational study for patients who come to the hospital
with unexplained pain symptoms
and wish to be treated with
MSC-CM.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perform pain and functional assessment prior to administration of the study drug, pain and functional assessment 30 minutes after administration, pain and functional assessment 24 hours after administration, pain and functional assessment 7days after administration,pain and functional assessment 14 days after administration
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Men and women between the ages of 20 and 80 years old.
2.Patients with pain symptoms in the following areas Neck. Shoulder joint. Knee joint Lower back. Ankle joint (including foot)
3.Patients who have given written consent to participate in the study
Key exclusion criteria
1. Patients who have taken anti-inflammatory analgesics within 8 hours prior to the administration of the study drug
2. Patients who have used sleeping pills, psychotropic drugs, or other psychiatric drugs within 24 hours prior to administration of the study drug
3. Patients suffering from infectious diseases
4. Patients with a history of cancer or active malignancy
5. Patients with hypoglycemic symptoms prior to administration of the study drug
6. Patients who are judged to be inappropriate as research subjects by the principal investigator and principal study investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Noguchi |
Organization
General incorporated association
Advalife Science
SINCLAIR GINZA CLINIC
Division name
Medical department
Zip code
104-0061
Address
8-19, Ginza 2-chome, Chuo-ku, Tokyo, Japan
TEL
0335386082
m-noguchi@s-gc.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Masuyama |
Organization
General incorporated association Advalife Science SINCLAIR GINZA CLINIC
Division name
Nursing Deptment
Zip code
104-0061
Address
8-19, Ginza 2-chome, Chuo-ku, Tokyo, Japan
TEL
03-3538-6082
Homepage URL
masuyama@s-gc.jp
Sponsor or person
Institute
General incorporated association
Advalife Science
SINCLAIR GINZA CLINIC
Institute
Department
Personal name
Funding Source
Organization
General incorporated association
Advalife Science
SINCLAIR GINZA CLINIC
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
Applied Biopharmatech Kurume Clinical Pharmacology Clinic Clinical Trial Review Committee
Address
Building B, Kurume University School of Medicine, 67 Asahi-cho, Kurume-shi, Fukuoka
Tel
0942-35-3705
Info_01@kurumecp.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
| 2022 | Year | 12 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Items
Pain assessment Using NRS
Functional assessment
Using Questionnaire
Hematological examination
Hematological and biochemical tests
Vital signs
Investigation of
Diseases and Adverse drug reactions
Prohibited, restricted,
and concomitant medications
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056641
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
