Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00458250
Status:
COMPLETED
Last Update Posted:
2008-11-18
First Post:
2007-04-07
Brief Title:
Feasibility of Haploidentical Hematopoietic Stem Cell Transplantation Using CAMPATH-1H
Sponsor:
Tehran University of Medical Sciences
Organization:
Tehran University of Medical Sciences
Study Overview
Official Title:
Haploidentical Hematopoietic Stem Cell Transplantation in the Treatment of Hematological Malignancies Using CAMPATH-1H
Status:
COMPLETED
Status Verified Date:
2008-11
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:
Many patients suffering various malignant and non-malignant diseases need hematopoietic stem cell transplantation from a healthy person In the majority of cases there is no matched related or unrelated donor
Some researchers have been performed transplantation from semi-matched haploidentical related donors with relatively good results
Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and their reports indicates good results
Chinese populations have more homogenous genetic background than Iranians In this project we are going to study the feasibility of this method of haploidentical transplantation in Iranian patients
Some researchers have been performed transplantation from semi-matched haploidentical related donors with relatively good results
Chinese researchers have been performed this kind of transplantation using CAMPATH-1H and their reports indicates good results
Chinese populations have more homogenous genetic background than Iranians In this project we are going to study the feasibility of this method of haploidentical transplantation in Iranian patients
Detailed Description:
Haploidentical hematopoietic stem cell transplantation is a very important therapeutic intervention for treatment of some genetic disorders and hematological malignancies
In the majority of cases there is no matched related or unrelated donor Haploidentical hematopoietic stem cell transplantation is a promising alternative for critical cases
To avoid severe graft versus host disease GVHD two types of T cell depletion TCD had been used total TCD and partial TCD
Total TCD has disadvantages such as increased rate of rejection and relapse and increased rate of infections due to delayed immune reconstitution
Partial TCD has been done by in vivo andor in vitro methods In haploidentical transplantation donor partial TCD ex vivo TCD without recipient TCD increases the rate of rejection and can not prevent severe GVHD successfully
In vivo TCD by partial depletion of donor and recipient T cells has been done in haploidentical transplantation with good results to some extent inferior to full matched transplantations by using CAMPATH ATG etc
Most of these studies have been performed in Chinese and Japanese populations that have more homogenous genetic background than other populations
In order to study the feasibility of this kind of transplantation in Iranian patients we defined a project to perform haploidentical hematopoietic stem cell transplantation by using in vivo CAMPATH-1H
In the majority of cases there is no matched related or unrelated donor Haploidentical hematopoietic stem cell transplantation is a promising alternative for critical cases
To avoid severe graft versus host disease GVHD two types of T cell depletion TCD had been used total TCD and partial TCD
Total TCD has disadvantages such as increased rate of rejection and relapse and increased rate of infections due to delayed immune reconstitution
Partial TCD has been done by in vivo andor in vitro methods In haploidentical transplantation donor partial TCD ex vivo TCD without recipient TCD increases the rate of rejection and can not prevent severe GVHD successfully
In vivo TCD by partial depletion of donor and recipient T cells has been done in haploidentical transplantation with good results to some extent inferior to full matched transplantations by using CAMPATH ATG etc
Most of these studies have been performed in Chinese and Japanese populations that have more homogenous genetic background than other populations
In order to study the feasibility of this kind of transplantation in Iranian patients we defined a project to perform haploidentical hematopoietic stem cell transplantation by using in vivo CAMPATH-1H
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None