Clinical trial • Phase III • Immunology

MCA-derived mesenchymal stromal cells (MSC) for Kidney transplant rejection | Biopsy-proven acute rejection (BPAR)

Phase III trial of MCA-derived mesenchymal stromal cells (MSC) for Kidney transplant rejection | Biopsy-proven acute rejection (BPAR). 16 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Kidney transplant rejection | Biopsy-proven acute rejection (BPAR)
Trial Stage
Phase III
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
19-08-2024
First CTIS Authorization Date
30-09-2024

Trial design

Phase III trial across 1 site in Netherlands.

Target Sample Size
16

Eligibility

Recruits 16 Vulnerable population not selected; no consent or assent details provided..

Vulnerable Population
Vulnerable population not selected; no consent or assent details provided.

Recruitment

Planned Sample Size
16
Recruitment Window Months
24

Geography

Total Number Of Sites
1
Total Number Of Participants
16

Netherlands

Earliest CTIS Part Ii Submission Date
29-08-2024
Latest Decision Or Authorization Date
30-09-2024
Processing Time Days
32
Number Of Sites
1
Number Of Participants
16

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Nephrology
Principal Investigator Name
H.S. Spijker
Principal Investigator Email
h.s.spijker@lumc.nl
Contact Person Name
H.S. Spijker
Contact Person Email
h.s.spijker@lumc.nl
Number Of Participants
16

Sponsor

Primary sponsor

Full Name
Leids Universitair Medisch Centrum (LUMC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
MCA-derived MSC therapy
Active Substance
MCA-derived mesenchymal stromal cells (MSC)
Modality
Cell therapy

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