Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-29 @ 12:11 AM
Study NCT ID:
NCT05132166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-22
First Post:
2021-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Phase II Study to Compare the Potential Long-Lasting Positive Effect of Decidual Stromal Cells to the Best Available Treatment in Graft Versus Host Disease
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
A Randomized, Open-label Phase II Trial Comparing Durable Overall Response Rate at 56 Days in Patients With Steroid-resistant Severe Acute GvHD After Allogeneic HSCT Treated With Decidual Stromal Cells or Best Available Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an academic open-label, phase II randomized study in patients with steroid resistant severe acute Graft versus host disease (GvHD) who have had allogeneic hematopoietic stem cell transplantation. The main purpose of this study is to compare the efficacy of Decidual Stromal Cells (DSC) with Investigators choice best available treatment (BAT). If randomized to DSC arm, patients will receive 2 infusions in the vein at least one week apart. Additional doses (up to 4 doses) of DSC may be given depending on response.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: