UMIN-CTR Clinical Trial

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
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Purpose of intervention
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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
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Results
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Results Delayed
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Baseline Characteristics
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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
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Research case data
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