Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058578
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2003-04-08
Brief Title:
Stem Cell Transplant to Treat Patients With Systemic Sclerosis
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin and certain organs It is possible that by changing the immune system we can modify the progression of this disease
Stem cells are created in the bone marrow They mature into different types of blood cells that are needed including red blood cells white blood cells and platelets In this study we will stimulate the bone marrow to make extra stem cells Next we will collect the stem cells select specific cells and store them We will then give high dose chemotherapy that will destroy the patients immune system We will then give back the selected stem cells we collected We believe that these selected stem cells may be able to re-create the immune system without the portion that causes Systemic Sclerosis
The purpose of this study is to try to discover if stem cell transplantation can help patients with Systemic Sclerosis We will also try to learn what the side effects are of this treatment in patients with Systemic Sclerosis We hope that this treatment will help to relieve the symptoms patients are experiencing although we do not know if it will
Stem cells are created in the bone marrow They mature into different types of blood cells that are needed including red blood cells white blood cells and platelets In this study we will stimulate the bone marrow to make extra stem cells Next we will collect the stem cells select specific cells and store them We will then give high dose chemotherapy that will destroy the patients immune system We will then give back the selected stem cells we collected We believe that these selected stem cells may be able to re-create the immune system without the portion that causes Systemic Sclerosis
The purpose of this study is to try to discover if stem cell transplantation can help patients with Systemic Sclerosis We will also try to learn what the side effects are of this treatment in patients with Systemic Sclerosis We hope that this treatment will help to relieve the symptoms patients are experiencing although we do not know if it will
Detailed Description:
Before the transplant the research participant will receive daily G-CSF Neupogen for 5-6 days This medication will help to stimulate the production of white blood cells WBC that will be used for the stem cell transplant The G-CSF will be given as an injection into the arm
If G-CSF does not stimulate the stem cells sufficiently the patient will receive a single dose of drug called cyclophosphamide chemotherapy intravenously into a vein This drug will cause the blood cell counts to fall A drug called MESNA will also be given to help protect the bladder from the Cyclophosphamide After completing chemotherapy patients will be started on G-CSF again until blood cell counts reach a certain level at which time the patient will undergo leukopheresis Leukopheresis is a procedure where blood is removed from one arm pumped into a machine where the white blood cells are separated from most of the other cells and then returned through the same needle or through a needle in the other arm This procedure usually takes 3 to 4 hours a day for up to 4 days in a row depending on how many cells are collected each time
After collection of the white blood cells special agents called monoclonal antibodies will be used in the laboratory to select out certain types of white blood cells CD34 cells The blood cells will be separated on a machine which picks out stem cells
After leukopheresis patients will receive drugs called cyclophosphamide and Mesna They will also receive a drug called Atgam and radiation treatment to the entire body This treatment will kill most of the blood forming cells in the bone marrow We will then give the CD34 cells that were collected during leukopheresis
After the transplant patients will be followed closely the same as any patient who receives a stem cell transplant This follow-up will involve blood tests to see how the body is recovering after the chemotherapy and radiation and a bone marrow aspiration once a year for 2 years
If G-CSF does not stimulate the stem cells sufficiently the patient will receive a single dose of drug called cyclophosphamide chemotherapy intravenously into a vein This drug will cause the blood cell counts to fall A drug called MESNA will also be given to help protect the bladder from the Cyclophosphamide After completing chemotherapy patients will be started on G-CSF again until blood cell counts reach a certain level at which time the patient will undergo leukopheresis Leukopheresis is a procedure where blood is removed from one arm pumped into a machine where the white blood cells are separated from most of the other cells and then returned through the same needle or through a needle in the other arm This procedure usually takes 3 to 4 hours a day for up to 4 days in a row depending on how many cells are collected each time
After collection of the white blood cells special agents called monoclonal antibodies will be used in the laboratory to select out certain types of white blood cells CD34 cells The blood cells will be separated on a machine which picks out stem cells
After leukopheresis patients will receive drugs called cyclophosphamide and Mesna They will also receive a drug called Atgam and radiation treatment to the entire body This treatment will kill most of the blood forming cells in the bone marrow We will then give the CD34 cells that were collected during leukopheresis
After the transplant patients will be followed closely the same as any patient who receives a stem cell transplant This follow-up will involve blood tests to see how the body is recovering after the chemotherapy and radiation and a bone marrow aspiration once a year for 2 years
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 |
|---|---|---|---|
| Systemic Sclerosis | None | None | None |