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Immune Suppression Treatment for Sickle Cell Disease
Study Summary
This trial is studying a new way of doing an HCT: using drugs to lower the activity of the body's immune system before transplanting healthy stem cells to replace diseased or damaged cells.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had 2 or more episodes of prolonged erections in the last 2 years.I have had a bone marrow transplant from a donor.I have not had a stroke or brain surgery in the last 6 months.I am mostly active and can care for myself.I do not have any uncontrolled infections.I have thalassemia of any genetic type.I have mild liver fibrosis, not severe cirrhosis.My kidney function is good, as per the Schwartz formula.My lung function test shows I can breathe well enough, or if I'm under 7, my oxygen level is above 92% without help.I have had at least 2 episodes of acute chest syndrome in the last 2 years.My major organs are functioning well.I have SCD with complications.My direct bilirubin levels are within normal range.I am between 13 and 34 years old, or 2-12/35-50 with specific trial conditions met.I am not pregnant and can bear children.I've had 3 or more pain crises in the last 2 years.I have had osteomyelitis or osteonecrosis.I have received more than 225 mL/kg of red blood cells in a year or over 15 transfusions in my lifetime.I have an enlarged liver and spleen.I, or my legal guardian, can sign the consent form. If I'm 7-17, I can agree to participate.I am over 18 and my kidney function is good.I have had a neurological event that caused lasting symptoms for more than a day.I have active hepatitis B or C.I have been cancer-free for at least 2 years, except for certain skin or cervical conditions.I needed blood transfusions regularly since I was a baby.
- Group 1: Participants with Sickle Cell Disease or β-Thalassemia
- 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
Does this research project accept individuals aged 45 or older as participants?
"Per the trial's criteria, individuals between 2 and 50 years old are eligible for enrollment."
May I be eligible to join this experiment?
"Eligibility to this medical trial necessitates that patients have thalassemia and are between 2-50 years old. The goal is to recruit around 24 participants for the clinical study."
Are any enrollees being welcomed into this research initiative currently?
"Correct. Clinicaltrials.gov testifies that this trial is actively enrolling patients; it was initially posted on February 9th, 2023 and the most recent edit occurred on the 17th of February 2023. The study requires 24 individuals to be selected from 6 different medical sites."
How many centers are responsible for coordinating the progress of this trial?
"The current trial is recruiting out of 6 sites, including Montvale, Middletown and Commack. It would be beneficial to select the closest one in order to reduce travel costs incurred when joining this study."
What is the maximum capacity for participants in this experiment?
"Affirmative. Clinicaltrials.gov's records demonstrate that this clinical trial, which was initially advertised on February 9th 2023 is actively seeking participants. Around 24 people must be enrolled from 6 associated medical centres."
What health risks do those with Sickle Cell Disease or β-Thalassemia face?
"Our team at Power has assessed the safety of individuals suffering from Sickle cell Disease or β-Thalassemia as a 2 due to its current Phase 2 status. While there is evidence affirming some measure of protection, no data exists in support of efficacy."
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