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Stem Cell Transplant for Sickle Cell Disease (PRECIZN-1 Trial)
PRECIZN-1 Trial Summary
This trial is testing a new treatment for sickle cell disease which involves transplanting stem cells. The goal is to evaluate the safety and effectiveness of the treatment.
PRECIZN-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPRECIZN-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PRECIZN-1 Trial Design
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Who is running the clinical trial?
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- I have had cancer or a blood cancer in the last 5 years, or my family has a history of cancer.I have severe sickle cell disease with major symptoms or complications.I have completed all my cancer screenings recommended for my age.I haven't taken any prohibited medications in the last 30 days.I cannot use plerixafor, undergo apheresis, or take busulfan due to health reasons.I have seizures that are not controlled by medication.I have undergone gene therapy before.I currently have a serious infection.I have a genetic variant affecting my blood's oxygen use.My blood has a high level of fetal hemoglobin.I am between 18 and 40 years old.I have been diagnosed with sickle cell disease.My heart, lungs, kidneys, and liver are working well.I am willing to use double contraception, accept blood transfusions, and stop taking hydroxyurea as required.I have a history of serious bleeding problems.I have had a stem cell or organ transplant before.I understand the study's risks and goals and can sign the consent form.I do not have major issues with my brain, kidneys, liver, lungs, or heart.I am healthy enough for stem cell collection and a stem cell transplant.
- Group 1: BIVV003
- 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
What criteria must potential participants meet to be eligible for this investigation?
"Prospective participants must have been diagnosed with anemia and sickle cell, as well as be between 18 and 40 years old to be considered for this medical trial. The total number of individuals accepted is limited to 8 persons."
Are geriatric individuals excluded from participating in this experiment?
"Within the bounds of 18 and 40 years old, this study is allowing individuals to join."
How pervasive is the clinical trial in this city?
"Karmanos Cancer Institute in Detroit, Michigan (Investigational Site Number 101), Children's Hospital of Philadelphia_Investigational site number 108 in Philadelphia, Pennsylvania and 6 other clinical trial sites are participating in this study."
What diseases is BIVV003 known to ameliorate?
"BIVV003 is a popular medication for treating leukemia, as well as allogeneic hematopoietic stem cell transplant, chronic myelogenous leukemia, conditioning regimens for allogenic stem cell transplantation therapy and thrombocythemia-essential."
Can you tell me what prior research has been done concerning BIVV003?
"Currently, there are 114 trials in progress researching the effects of BIVV003. Out of these experiments, 13 have reached Phase 3 and they all originate from Philadelphia, Pennsylvania - however, there are 1113 different sites running studies related to this drug."
Are there any enrollment opportunities for this clinical trial at the present time?
"Indeed, the clinicaltrials.gov portal states that this medical trial is enrolling patients. First advertised on March 6th 2019 and most recently updated on September 13th 2022, 8 participants are sought from six distinct sites."
What is the sample size for this trial?
"To properly execute this trial, 8 individuals that meet the criteria must be recruited. The primary sponsor and manager of the study is Bioverativ (a Sanofi company). Karmanos Cancer Institute in Detroit, Michigan and Investigational Site Number 101 located in Bethesda, Maryland are two sites where recruiting will take place."
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