UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048061
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email osahiko.z8@keio.jp

Sponsor
Institute Keio University
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.