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Production of placenta derived decidual stromal cells for clinical use

Status Approved

First Submitted Date

2020/07/23
Registered Date

2020/08/04
Last Updated Date

2020/07/30

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005291
Unique Protocol ID	KC20TDSE0397
Public/Brief Title	Production of placenta derived decidual stromal cells for clinical use
Scientific Title	Production of placenta derived decidual stromal cells for clinical use
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC20TDSE0397
Approval Date	2020-07-03
Institutional Review Board Name	The Catholic University Seoul St. Mary's Hospital Institutional Review Board
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Hyun Sun Ko
Title	Professor
Telephone	+82-2-2258-3021
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 Banpo-daero, Seocho-gu, Seoul
Contact Person for Public Queries
Name	Hyun Sun Ko
Title	Professor
Telephone	+82-2-2258-3021
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 Banpo-daero, Seocho-gu, Seoul
Contact Person for Updating Information
Name	Nayoun Kim
Title	Production Director
Telephone	+82-2-2258-7844
Affiliation	LucasBio
Address	222 Banpo-daero, Seocho-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-07-13 Actual
Target Number of Participant	120
Primary Completion Date	2025-03-31 , Anticipated
Study Completion Date	2025-03-31 , Anticipated
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-07-13 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	LucasBio
Organization Type	Others
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Research Objective: Production of clinical-grade placenta derived decidual mesenchymal stromal cells Mesenchymal stromal cells, which are adult stem cells, display unique expression patterns in cell surface molecules, and are fibroblasts with high proliferation and adhesion, intermediate such as bone, cartilage, muscle, ligament, fat, and matrix. t plays an important role in regenerating lobe tissues and supporting the differentiation and growth of hematopoietic stem cells (HSC) in the microenvironment of the bone marrow. Due to these characteristics, mesenchymal stromal cells have been recognized as an attractive tool in the concept of cell therapy and tissue replacement for various diseases. Bone marrow is currently known to be a major source of stem cells and has been applied in many pre-clinical and clinical studies. However, Stem cells derived from bone marrow show a marked decrease in proliferative ability and have a high frequency of viral infections in donors with older age. There are also disadvantages such as invasive collection and further improvement in terms of determining clinical effectiveness and availability are needed. Therefore, it is necessary to develop a stem cell source that has better cell proliferation capacity, low virus infection rate, and unlimited source than bone marrow. Recently, there have been reports that stem cells can be separated from peripheral blood of the fetus, fetal liver, fetal spleen, placenta, umbilical cord, umbilical cord blood, amniotic fluid, amniotic membrane and various other adult tissues. In particular, it has been found that the placental membrane of the placenta is not only easily collected after delivery, but is also associated with immunomodulatory effects as it has been used in burn therapies for the past century. Stem cells or mesenchymal stem cells derived from decidual membranes (also known as decidual stromal cells, DSCs) have been reported to have more proliferation capacity than bone marrow derived MSCs and are also relative smaller in cell size. Therefore, it has the advantage of being able to produce more cells. In addition, unlike MSCs of bone marrow origin, it can be obtained from medical by-products and thus can be supplied without restriction of donor requirements. Therefore, DSCs are emerging as a new alternative for the treatment of immune and inflammatory diseases. Therefore our study is focused on establishing a manufacturing platform of placental membrane derived decidual stromal cells to develop a cellular therapeutic agent for clinical trials in the future.

Study Summary Information

Lay Summary

Research Objective: Production of clinical-grade placenta derived decidual mesenchymal stromal cells

Mesenchymal stromal cells, which are adult stem cells, display unique expression patterns in cell surface molecules, and are fibroblasts with high proliferation and adhesion, intermediate such as bone, cartilage, muscle, ligament, fat, and matrix. t plays an important role in regenerating lobe tissues and supporting the differentiation and growth of hematopoietic stem cells (HSC) in the microenvironment of the bone marrow. Due to these characteristics, mesenchymal stromal cells have been recognized as an attractive tool in the concept of cell therapy and tissue replacement for various diseases.

Bone marrow is currently known to be a major source of stem cells and has been applied in many pre-clinical and clinical studies. However, Stem cells derived from bone marrow show a marked decrease in proliferative ability and have a high frequency of viral infections in donors with older age. There are also disadvantages such as invasive collection and further improvement in terms of determining clinical effectiveness and availability are needed. Therefore, it is necessary to develop a stem cell source that has better cell proliferation capacity, low virus infection rate, and unlimited source than bone marrow.

Recently, there have been reports that stem cells can be separated from peripheral blood of the fetus, fetal liver, fetal spleen, placenta, umbilical cord, umbilical cord blood, amniotic fluid, amniotic membrane and various other adult tissues. In particular, it has been found that the placental membrane of the placenta is not only easily collected after delivery, but is also associated with immunomodulatory effects as it has been used in burn therapies for the past century. Stem cells or mesenchymal stem cells derived from decidual membranes (also known as decidual stromal cells, DSCs) have been reported to have more proliferation capacity than bone marrow derived MSCs and are also relative smaller in cell size. Therefore, it has the advantage of being able to produce more cells. In addition, unlike MSCs of bone marrow origin, it can be obtained from medical by-products and thus can be supplied without restriction of donor requirements.

Therefore, DSCs are emerging as a new alternative for the treatment of immune and inflammatory diseases. Therefore our study is focused on establishing a manufacturing platform of placental membrane derived decidual stromal cells to develop a cellular therapeutic agent for clinical trials in the future.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Others (Human Resource Study- Cell Therapy)
Phase	Not applicable
Intervention Model	Others (Human Resource Study- Cell Therapy)
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	/Biological/Vaccine, Stem Cell, Others (Human Resource Study- Cell Therapy)
Intervention Description	Collection of placental membrane from cesarean surgery
Number of Arms	1
Arm 1	Arm Label Collection of placental membrane from cesarean surgery
	Target Number of Participant 120
	Arm Type Experimental
	Arm Description Collection of placental membrane from cesarean surgery

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Etc Pregnant donors undergoing cesarean surgery
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~40Year
	Description 1. Those who consent to the study 2. Those expecting a cesarean surgery
Exclusion Criteria	1. Those who do not consent 2. Those with genetic diseases or chromosomal abnormalities 3. Positive for HIV antibody or hepatitis B and C carriers 4. Positive for syphillis
Healthy Volunteers

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Culturing and inducing DSCs from the placental decidual membrane
Timepoint	Approximately on day+21 when the cells reach passage 3
Secondary Outcome(s) 1
Outcome	Evaluating the fold expansion of DSCs
Timepoint	On the day of culture and approximately on day+21 when the cells reach passage 3
Secondary Outcome(s) 2
Outcome	Evaluating the immunomodulatory capacity of DSCs through analysis of cytokine secretion and imunomodulatory molecules
Timepoint	Approximately on day+21 when the cells reach passage 3
Secondary Outcome(s) 3
Outcome	Evaluating the therapeutic effects of DSCs through treatment of in vivo mouse GVHD model
Timepoint	Approximately on day+21 when the cells reach passage 3

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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