Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01189786
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2010-08-25
Brief Title:
Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Ex Vivo T-Cell Depletion of Mobilized Peripheral Blood Stem Cells Via CD34-Selection EXCESS
Status:
RECRUITING
Status Verified Date:
2024-06
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:
EXCESS
Brief Summary:
Participants are being asked to take part in this study because treatment of his or her disease requires a stem cell transplant Stem cells or mother cells are the source of normal blood cells and lead to recovery of blood counts after bone marrow transplantation Unfortunately there is not a perfectly matched stem cell donor like a sister or brother for the participant and his or her disease does not permit enough time to identify another donor like someone from a registry list that is not his or her relative or another suitable donor has not been identified However a close relative of the patient has been identified whose stem cells are not a perfect match but can be used
Alternatively the patient may have already received a stem cell transplant but have evidence of mixed chimerism which means some of the patients own bone marrow cells are present rather than all of the donors cells This may lead to an increased risk of the disease coming back Or the patient may have all donor cells but his or her bone marrow is not working very well which may lead to frequent blood or platelet cells that help in clotting blood transfusions or infection
Regardless of the reason it may be necessary to isolate stem cells from a haploidentical half-match donor in order to provide bone marrow function Because the stem cells from the donor are only half-matched to the participant the risk of graft-versus-host disease GvHD is very high GvHD is a complication after transplant caused by donor T cells graft that attack the transplant recipient and this complication can cause death after transplant Thus it is important that the donors blood cells are treated to minimize cells that are most likely to attack the hosts tissues This is done by using a special device to capture the CD34 stem cells from the donors stem cell product prior to giving the cells to the host This method minimizes the donor T cells which are responsible for causing GvHD
Purpose In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure investigators would like to specially treat the donors blood cells to minimize the cells that are most likely to attack the patients tissues
Alternatively the patient may have already received a stem cell transplant but have evidence of mixed chimerism which means some of the patients own bone marrow cells are present rather than all of the donors cells This may lead to an increased risk of the disease coming back Or the patient may have all donor cells but his or her bone marrow is not working very well which may lead to frequent blood or platelet cells that help in clotting blood transfusions or infection
Regardless of the reason it may be necessary to isolate stem cells from a haploidentical half-match donor in order to provide bone marrow function Because the stem cells from the donor are only half-matched to the participant the risk of graft-versus-host disease GvHD is very high GvHD is a complication after transplant caused by donor T cells graft that attack the transplant recipient and this complication can cause death after transplant Thus it is important that the donors blood cells are treated to minimize cells that are most likely to attack the hosts tissues This is done by using a special device to capture the CD34 stem cells from the donors stem cell product prior to giving the cells to the host This method minimizes the donor T cells which are responsible for causing GvHD
Purpose In an effort to lower the occurrences and severity of graft-versus-host disease in patients and to lower the rate of transplant failure investigators would like to specially treat the donors blood cells to minimize the cells that are most likely to attack the patients tissues
Detailed Description:
Participation in this project will last approximately one year with follow-up exams
Before treatment can begin stem cells will be collected from the donor a close relative that has been selected as the best match for the participant White blood cells will be collected from the donor The cells will then be mixed with a special protein called a CD34 antibody that binds to the stem cells which will then be separated out from the white blood cells by a special machine- called a CliniMACS CD34 Reagent System in the laboratory This is an investigational device that is not approved by the FDA Although this device is not approved for use in this country it has been in use for years and is approved in other countries The stem cells will be collected and frozen before they will be given to the participant
On about days 28 60 100 180 and 365 after the transplant the participant will have the same testsevaluations since the time of transplant For patients who do not develop GvHD they are not required to have these testsevaluations
In addition for purposes of the study health-related information will be collected for a year from the time of stem cell infusion This will be used to determine survival relapse infections and GvHD that may occur following transplant
Before treatment can begin stem cells will be collected from the donor a close relative that has been selected as the best match for the participant White blood cells will be collected from the donor The cells will then be mixed with a special protein called a CD34 antibody that binds to the stem cells which will then be separated out from the white blood cells by a special machine- called a CliniMACS CD34 Reagent System in the laboratory This is an investigational device that is not approved by the FDA Although this device is not approved for use in this country it has been in use for years and is approved in other countries The stem cells will be collected and frozen before they will be given to the participant
On about days 28 60 100 180 and 365 after the transplant the participant will have the same testsevaluations since the time of transplant For patients who do not develop GvHD they are not required to have these testsevaluations
In addition for purposes of the study health-related information will be collected for a year from the time of stem cell infusion This will be used to determine survival relapse infections and GvHD that may occur following transplant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EXCESS | OTHER | Baylor College of Medicine | None |