Ignite Creation Date:
2024-05-06 @ 12:46 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03847844
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-03
First Post:
2019-02-14
Brief Title:
UCMSCs as Front-line Approach of Treatment for Patients With aGVHD
Sponsor:
Cytopeutics Sdn Bhd
Organization:
Cytopeutics Sdn Bhd
Study Overview
Official Title:
Cytopeutics Umbilical Cord Mesenchymal Stem Cells Cyto-MSC for Patients With Grade II -IV Acute Graft-Versus-Host Disease A Phase III Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
GVHD Cyto-MSC
Brief Summary:
Background Graft-versus-host disease GVHD is a devastating complication following allogeneic hematopoietic stem cell transplantation HSCT mediated by stimulation of antigen presenting cells APCs which leads to donor T-lymphocytes activation and target tissue destruction particularly affecting the skin gastrointestinal tract and liver in acute setting In recent years researchers have discovered that the application of mesenchymal stromal cells MSCs as salvage treatment among steroid refractory GVHD patients improves outcomes without long-term risk association On the other hand the use of MSCs concurrently with steroids as front-line treatment for acute GVHD has yet to be researched on The investigators hypothesize that this approach as the MSCs will be administered at earlier stage of the disease will increase survival rate and reduce mortality among aGVHD patients
Objective In this study the investigators aim to determine the efficacy and safety of allogeneic infusion of Cytopeutics umbilical cord-derived mesenchymal stromal cells Cyto-MSC in combination of standard corticosteroid therapy as front-line approach for treatment of grade II-IV acute GVHD patients
Study design This is a phase III clinical study involving patients who underwent an allogeneic HSCT for malignant or non malignant haematological disorders and developed grade II-IV acute GVHD A total of 40 eligible patients will be recruited in this study
For Phase I open labelled study 5 eligible patients will be recruited to receive Cyto-MSC 5 million UC-MSCs per kg bodyweight and standard treatment Meanwhile for Phase II double blinded placebo controlled study another 35 eligible patients will be recruited and randomized into 2 study groups where 15 patients will be assigned into Group A to receive Cyto-MSC 5 million UCMSCs per kg bodyweight and standard treatment meanwhile another 20 patients will be assigned into Group B to receive Placebo and standard treatment
Cyto-MSC or Placebo will be administered at Day 1 and Day 4 Another infusion of Cyto-MSC or Placebo will be given at Day 7 if the patient shows no or partial response based on GvHD grading criteria All patients will be assessed up until 6 months follow-up which include medical history clinical and physical evaluations pathology investigations biomarkers and immune cell subsets analysis as well as quality of life questionnaires
Objective In this study the investigators aim to determine the efficacy and safety of allogeneic infusion of Cytopeutics umbilical cord-derived mesenchymal stromal cells Cyto-MSC in combination of standard corticosteroid therapy as front-line approach for treatment of grade II-IV acute GVHD patients
Study design This is a phase III clinical study involving patients who underwent an allogeneic HSCT for malignant or non malignant haematological disorders and developed grade II-IV acute GVHD A total of 40 eligible patients will be recruited in this study
For Phase I open labelled study 5 eligible patients will be recruited to receive Cyto-MSC 5 million UC-MSCs per kg bodyweight and standard treatment Meanwhile for Phase II double blinded placebo controlled study another 35 eligible patients will be recruited and randomized into 2 study groups where 15 patients will be assigned into Group A to receive Cyto-MSC 5 million UCMSCs per kg bodyweight and standard treatment meanwhile another 20 patients will be assigned into Group B to receive Placebo and standard treatment
Cyto-MSC or Placebo will be administered at Day 1 and Day 4 Another infusion of Cyto-MSC or Placebo will be given at Day 7 if the patient shows no or partial response based on GvHD grading criteria All patients will be assessed up until 6 months follow-up which include medical history clinical and physical evaluations pathology investigations biomarkers and immune cell subsets analysis as well as quality of life questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None