UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048061 |
|---|---|
| Receipt number | R000054777 |
| Scientific Title | Extraction and evaluation of mesenchymal stem cells from bone marrow aspirate. |
| Date of disclosure of the study information | 2022/06/14 |
| Last modified on | 2022/06/14 20:11:45 |
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Basic information
Public title
Extraction and evaluation of mesenchymal stem cells from bone marrow aspirate.
Acronym
MSCs from bone marrow
Scientific Title
Extraction and evaluation of mesenchymal stem cells from bone marrow aspirate.
Scientific Title:Acronym
MSCs from bone marrow
Region
| Japan |
Condition
Condition
Musculoskeletal diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among the various types of cells used in regenerative medicine, human mesenchymal stem cells have the ability to differentiate into bone, cartilage, and muscle, and their versatility has attracted considerable attention. Mesenchymal stem cells are isolated, cultured, and purified mainly from bone marrow. However, even at the research level, human iliac bone marrow fluid, the raw material for mesenchymal stem cells, is currently purchased from imported lumber products. Therefore, the most urgent issue to be solved is how to secure the raw materials for human mesenchymal stem cells in order to commercialize and industrialize them.
To establish a stable supply system for cell source materials, the ideal source would be the surplus specimens discarded or provided in large quantities during musculoskeletal surgeries, but detailed studies on which parts of the surgical surplus specimens should be collected and how much of them would be a sufficient cell source have not been conducted. However, detailed studies have not yet been conducted on which parts of the surgical surplus specimen should be collected, how much of it is sufficient, etc. Therefore, the purpose of this study is to extract and culture mesenchymal stem cells from perioperatively derived tissues and cells of scoliosis patients during musculoskeletal surgery, to confirm the quality of the obtained stem cells, and to evaluate their eligibility as a cell source by comparing them with conventional stem cells derived from iliac bone.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Perioperatively derived cells obtained from scoliosis patients using cell surface antibodies such as CD73, CD90, CD105, and CD271 will be quantified for cellular components using flow cytometry.
2) The content ratio of the obtained mesenchymal stem cell markers and cell characteristics will be analyzed to see if they differ in each tissue to be harvested (e.g., thoracic spine, lumbar spine, iliac bone, etc.). In addition, cell surface antigens will be used as indicators for isolation, and cell functions will be evaluated by culture and transplantation experiments.
Key secondary outcomes
Evaluate gene expression (cell growth factor, bone-related genes, vascular endothelial cell growth factor, anti-inflammatory factor, etc.) and secreted factor components of mesenchymal stem cells isolated with various markers.
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients undergoing scoliosis surgery in the Department of Orthopaedic Surgery at Keio University Hospital from the time of approval by the Ethics Review Committee until the end of the collaborative study
2. patients between the ages of 16 and 75 years (patients with adolescent idiopathic scoliosis, the most common form of scoliosis, who are 16 years of age or older and who are considered capable of giving informed consent)
Patients who have given a full explanation of the sample donation, and who have given written consent to participate in this study of their own free will, based on a thorough understanding of the study (this was established from an ethical standpoint as a basic requirement for conducting the study).
Key exclusion criteria
1. patients who are judged by the physician in charge to be inappropriate to participate in this study (established as a basic requirement for conducting this study)
2. patients with infectious diseases such as hepatitis B, hepatitis C, HIV, HTLV-1, and syphilis (established as a safety precaution for specimen analysts in this study)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Namamura |
| Middle name | |
| Last name | Masaya |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan.
TEL
03-5363-3812
masa@keio.jp
Public contact
Name of contact person
| 1st name | Tsuji |
| Middle name | |
| Last name | Osahiko |
Organization
Keio University School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan.
TEL
03-5363-3812
Homepage URL
osahiko.z8@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Juntendo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics committee
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan.
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2022 | Year | 06 | Month | 14 | 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
| 2022 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 06 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054777
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