|
Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies Clinical research trials and Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies. Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies clinical trial. Human subjects often receive the most effective healthcare possible for their Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies  Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies
Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies
For Condition: Sickle Cell Anemia,Hemoglobinopathy,Thalassemia
Status: Terminated
Sponsor(s): Baylor College of Medicine , The Methodist Hospital,Texas Children's Hospital
Synopsis: The major goal of this study is to determine the risks and benefits of bone marrow transplants in patients with severe thalassemia or sickle cell disease. Participation in this project will be for two years.
Details: To do the bone marrow transplant, we must first kill the cells in the bone marrow that make the abnormal red blood cells that are found in patients with severe thalassemia or sickle cell disease. We will do this by using three drugs: busulfan, cyclophosphamide, and CAMPATH-1H. CAMPATH-IH is an investigational drug. CAMPATH-1H is used to prevent participants from rejecting or refusing to let the donor blood cells grow in the body. After the drug treatment, participants will be given bone marrow from a brother or sister who has healthy bone marrow that matches.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: Inclusion: - Patients with homozygous B0/+ thalassemia or severe variants of B0/+ thalassemia with an HLA genotypically identical donor. - Patients with an HLA genotype identical donor and hemoglobin SS, hemoglobin SC, or hemoglobin Sb 0/+ and at least one of the following: Previous central nervous system vaso-occlusive episode with or without residual neurologic findings; Frequent painful vaso-occlusive episodes which significantly interfere with normal life activities and which necessitate chronic transfusion therapy; Recurrent SCD chest syndrome events which necessitate chronic transfusion therapy. - Severe anemia which prevents acceptable quality of life and necessitates chronic transfusion therapy. - The patient must have an HLA genotype identical donor. - Between the ages of birth and 65 years. - Women of childbearing potential must have a negative pregnancy test. Exclusion: - Biopsy proven chronic active hepatitis or fibrosis with portal bridging. - SCD chronic lung disease >/= stage 3. - Severe renal dysfunction defined as creatinine clearance <40 ml/min/1.73 M2 - Severe cardiac dysfunction defined as shortening fraction <25%. - HIV infection. - Severe but unspecified chronic toxicity serious enough to detrimentally affect the patient's capacity to tolerate bone marrow transplant (BMT). - Inadequate intellectual capacity to understand the nature and risk inherent in the BMT process and give informed consent (in the case of minors, this criteria must be fulfilled by the legal guardian). - Pregnant, lactating or unwilling to use appropriate birth control.
Total Enrollment: 15
Location and Contact Information:
Overall Study Official:
MalcolmBrenner, Study Chair, Baylor College of Medicine
Texas Children's Hospital
Houston, Texas, 77030
United States
The Methodist Hospital
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: H6847; Scallo2
Study Start Date: August 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040469
Other Sickle Cell Anemia Studies:
1. Hydroxyurea to Treat Beta-Thalassemia (Cooley's Anemia)
2. Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies
3. Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
Related Studies:
Other Sickle Cell Anemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies
|
|
|
|
|
|
|
|
