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Haploidentical Bone Marrow Transplant for Sickle Cell Disease
Study Summary
This trial is testing whether haploidentical BMT (using a donor who is a half-match to the patient) is effective and safe in patients with sickle cell disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My direct bilirubin levels are within twice the normal limit, not due to blood transfusion issues.I need a liver MRI because I've had many blood transfusions.Your liver enzymes ALT and AST must be within the normal range.I have a relative who can donate bone marrow and matches me partially in HLA.I am not using umbilical cord or peripheral blood stem cells for my treatment.I had a surgery to improve brain blood flow within the last 6 months.You have participated in another research study that involved testing a new or unapproved drug or medical device within the past three months.My liver tests are within the required range and I may need a liver MRI due to my transfusion history.I have a family member who matches my HLA type and is willing to donate bone marrow.I am actively being treated for an autoimmune disease that is not under control.My kidney function is within the normal range for my age.I am not pregnant or breastfeeding.I can care for myself but may need occasional help.I am between 15 and 45 years old with sickle cell anemia and specific complications.I am a child aged 5 to 14 with sickle cell anemia and complications.I have had a bone marrow or stem cell transplant.Donors of umbilical cord blood or peripheral blood stem cells cannot participate.You have previously received an organ transplant.I have a sibling who matches my HLA type and can donate bone marrow.My heart's pumping ability is within the required range.My oxygen levels are good and my lungs work well enough to breathe properly.I am between 5 and 14 years old.I can do most activities, my heart and lungs work well enough for treatment.My body has antibodies against a donor organ.I agree to use two forms of birth control or practice true abstinence.I am a male and agree to use effective contraception or practice abstinence.
- Group 1: Haploidentical Transplantation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you please share how many other times this Haploidentical Bone Marrow Transplantation clinical trial has been conducted?
"Haploidentical Bone Marrow Transplantation was first studied in 1997. As of now, there have been a total of 1442 completed studies with 981 trials actively recruiting patients. Many of these studies are being conducted in Washington D.C."
Could I be included as a subject in this experiment?
"This trial is looking for 80 patients with anemia, sickle cell between the ages of 5 and 45. Most notable, applicants should meet the following criteria: Umbilical cord blood or peripheral blood stem cell donors will not be accepted., A Karnofsky/Lansky performance score of ≥ 60., An HLA haploidentical first degree relative donor (parents, siblings or half siblings, or children) with 2, 3, or 4 (out of 8) HLA-mismatches who is willing and able to donate bone marrow. A unidirectional mismatch in either the graft versus host or host versus graft direction"
What are some of the risks associated with Haploidentical Bone Marrow Transplantation?
"While Phase 2 trials are not as reliable in terms of efficacy, the existing data on Haploidentical Bone Marrow Transplantation suggests that it is a safe medical procedure."
Are we still enrolling patients for this clinical trial?
"No, this study is not currently recruiting patients. It was last updated on October 11th, 2022 and had originally been posted on October 3rd, 2017. There are 1183 other trials with open recruitment at the moment."
What types of leukemia does Haploidentical Bone Marrow Transplantation typically target?
"Haploidentical Bone Marrow Transplantation is a treatment for malignant melanoma of skin that can also be used to fight leukemia, neoplasm metastasis, and sickle cell anemia."
Does this research include elderly individuals in its tests?
"According to the guidelines for who can participate in this research, individuals must be between 5 and 45 years old."
How many participants are being included in this clinical trial?
"This particular study is no longer enrolling patients. The listing originally went up on October 3rd, 2017 but the last update was on October 11th, 2022. However, there are currently 981 trials for Haploidentical Bone Marrow Transplantation and 202 clinical trials actively searching for patients with anemia or sickle cell disease."
Are there other hospitals in this state that are also running this trial?
"Currently, this study is enrolling patients at 27 sites. The locations are located in Washington, Buffalo and Cleveland along with other locations 27 other locations. To minimize travel demands, it is important to select the site nearest you if you enroll."
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