Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304025
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-01-19
Brief Title:
Sequential Administration of WJ-MSCs for the Treatment of GvHD Refractory to Second Line Treatment
Sponsor:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Organization:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Study Overview
Official Title:
Pilot Study Sequential Administration of Allogeneic Mesenchymal Stem Cells Thawed or Expanded in Vitro for the Treatment of Acute Graft-versus-host Disease Refractory to Second Line Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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
Brief Summary:
Hematopoietic stem cell transplantation HSCT is the treatment of choice for malignant hemopathies but highlights the limitations of long-term results due to the high toxicity of the procedure and the development of Graft versus Host Disease GVHD Conventional treatments for GVHD have limited success rates and some patients may be refractory to ruxolitinib a second-line treatment option As a result there is a need to explore alternative immuno-modulatory therapies such as the use of Whartons jelly mesenchymal stem cells WJ-MSCs
The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib
The research question aims to investigate the safety and potential benefits of sequentially infusing thawed or expanding allogeneic WJ-MSCs in the treatment of acute GVHD refractory to second-line treatment in patients from the Colombian population This pilot clinical study is being conducted to address the unmet need for patients who develop GVHD resistant to ruxolitinib
Detailed Description:
In recent decades the number of HSCTs has significantly increased as it is considered the ideal therapeutic approach for a wide range of hematological diseases However GVHD is the most common and severe complication following transplantation and it remains the major limiting factor for the success of HSCT It has been reported that the incidence of acute GVHD is approximately 50 in patients who receive HSCT from an HLA-matched donor and it increases in cases of HLA-mismatched donors despite having prophylactic treatment Patients who develop GVHD have a poor prognosis with a survival rate ranging from 5-25 depending on the severity of the disease This is strongly related to the lack of effective treatments In addition to the high morbidity and mortality GVHD represents a significant financial burden for public healthcare systems worldwide A recent study in 2018 in the United States reported that the cost of complete remission for a 6-month period with ruxolitinib one of the most commonly used treatments for both acute and chronic GVHD was 1187657 USD
In this context the American Society for Blood and Marrow Transplantation considers MSCs as a prominent therapeutic tool for the treatment of GVHD as they significantly improve both the symptoms of the most frequently affected organs skin liver and intestines and the treatment response parameters and overall survival Colombia is not exempt from this issue the rise of HSCT in our country is evident Therefore the development of a novel and effective therapeutic strategy for GVHD is a priority and demands further scientific research
Finally with the development of this pilot study the aim is to lay the groundwork for conducting medium- and large-scale clinical trials in our Colombian population where clinical studies with this type of therapeutic approach have not yet been conducted
In this context the American Society for Blood and Marrow Transplantation considers MSCs as a prominent therapeutic tool for the treatment of GVHD as they significantly improve both the symptoms of the most frequently affected organs skin liver and intestines and the treatment response parameters and overall survival Colombia is not exempt from this issue the rise of HSCT in our country is evident Therefore the development of a novel and effective therapeutic strategy for GVHD is a priority and demands further scientific research
Finally with the development of this pilot study the aim is to lay the groundwork for conducting medium- and large-scale clinical trials in our Colombian population where clinical studies with this type of therapeutic approach have not yet been conducted
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