A single-center, phase 1/2a clinical trial to evaluate the safety, maximum tolerated dose, and exploratory efficacy of MR-MC-01 treatment in patients with underactive bladder

General Information

Summary The purpose of the study is to verify the safety and effectiveness by conducting clinical trials to develop a treatment for underactive bladder, using a pluripotent mesenchymal stem cell treatment derived from allogeneic embryonic stem cells.
Clinical trials phase Phases 1/2
Start date (estimated) 2023-12-15
Clinical feature
Label Bladder dysfunction
Link http://snomed.info/id/40492006

Administrative Information

ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=KCT0009028
Sponsor Protocol number DUA-EMSC-MB-01
Other study identifiers
Name KCT0009028
Description CRIS Registration Number
Source weblink https://cris.nih.go.kr/cris/search/detailSearch.do?seq=23665&search_page=L
Approval number 2023-1258 (Board Approval Number)
Study sites
Public contact
Email seolajung2@gmail.com
Public email seolajung2@gmail.com
First name Seol a Jung
Last name Seol a Jung
Phone +82-2-3010-3735
City Seoul
Country
South Korea
Address freetext 1502-1503ho, 147, Seongsui-ro, Seongdong-gu, Seoul, Republic of Korea
Sponsors Mirae Cell Bio

Cells

Which differentiated cell type is used
Label mesenchymal stem cell
Link http://purl.obolibrary.org/obo/CL_0000134
Description A connective tissue cell that normally gives rise to other cells that are organized as three-dimensional masses. In humans, this cell type is CD73-positive, CD90-positive, CD105-positive, CD45-negative, CD34-negative, and MHCII-negative. They may further differentiate into osteoblasts, adipocytes, myocytes, neurons, or chondroblasts in vitro. Originally described as residing in the bone marrow, this cell type is now known to reside in many, if not all, adult organs.; Many but not all mesenchymal cells derive from the mesoderm. MSCs are reportedly CD3-negative, CD4-negative, CD5-negative, CD8-negative, CD11a-negative, CD11b-negative, CD14-negative, CD19-negative, CD29-positive, CD31-negative, CD34-negative, CD38-negative, CD40-negative, CD44-positive, CD45-negative, CD49-positive, CD54-positive, CD66b-negative, CD79a-negative, CD80-negative, CD102-positive, CD106-positive, CD117-positive, CD121a-positive, CD121b-positive, CD123-positive, CD124-positive, CD133-negative, CD146-positive, CD166-positive, CD271-positive, B220-negative, Gr1-negative, MHCI-positive, MHCII-negative, SSEA4-negative, sca1-positive, Ter119-negative, and glycophorin A-negative. Cultured MSCs are capable of producing stem cell factor, IL7, IL8, IL11, TGF-beta, cofilin, galectin-1, laminin-receptor 1, cyclophilin A, and MMP-2.

Recruitment

Recruitment Status Not yet recruiting
Estimated number of participants 33