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Cell Depletion
Stem Cell Selection for Blood Diseases
Phase 2
Recruiting
Research Sponsored by Mitchell Cairo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease)
High Risk Myelodysplastic syndrome (MDS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new stem cell selection method for children, adolescents, and young adults undergoing an AlloSCT. The new method uses α/β CD3+/CD19+ cell depletion to select the stem cells, and all other treatment is standard of care.
Who is the study for?
This trial is for children and young adults (0-30 years) with various blood diseases, including high-risk acute leukemia, lymphoma, sickle cell disease, and bone marrow failure syndromes. Participants must have adequate organ function and not be pregnant or breastfeeding. They can't join if they've had a recent transplant or uncontrolled infection.Check my eligibility
What is being tested?
The study tests a stem cell transplantation technique using α/β CD3+/CD19+ cell depletion in patients with malignant and non-malignant hematologic conditions. This method aims to improve outcomes by selecting specific cells while maintaining standard care treatments.See study design
What are the potential side effects?
While the description doesn't specify side effects of α/β T-cell depletion, similar procedures may include risks like infections due to lowered immunity, graft-versus-host disease where donor cells attack the body, bleeding complications from low platelet count, and reactions to infusion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Sickle Cell Disease.
Select...
I have been diagnosed with high-risk Myelodysplastic syndrome.
Select...
I have a bone marrow failure syndrome and treatments haven't worked for me.
Select...
I am 30 years old or younger.
Select...
I have AML and it has not responded well to initial treatments or it has come back.
Select...
My leukemia is considered high risk due to specific genetic features or because it didn't respond well to initial treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells
Secondary outcome measures
incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion
Trial Design
1Treatment groups
Experimental Treatment
Group I: alpha beta cell depletionExperimental Treatment1 Intervention
Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.
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Who is running the clinical trial?
Mitchell CairoLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Mitchell S CairoStudy ChairNew York Medical College
1 Previous Clinical Trials
32 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Sickle Cell Disease.I do not have any untreated infections.I am not pregnant or breastfeeding.I have been diagnosed with high-risk Myelodysplastic syndrome.I have a bone marrow failure syndrome and treatments haven't worked for me.My lymphoma (Hodgkin or Non-Hodgkin) has not responded well to initial treatment, or it has come back after treatment.I am 30 years old or younger.My organs are working well.I have AML and it has not responded well to initial treatments or it has come back.My leukemia is considered high risk due to specific genetic features or because it didn't respond well to initial treatment.I had a stem cell transplant from a donor less than 6 months ago, not as a boost.I need assistance with my daily activities due to my health condition.You have a history of not following medical instructions.My graft-versus-host disease is mild.
Research Study Groups:
This trial has the following groups:- Group 1: alpha beta cell depletion
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the qualifications to be included in this medical experiment?
"This clinical trial is seeking participants with congenital hypoplastic anemia between the ages of one day and 30 years old. The total number of enrollees for this study will be 20 individuals."
Answered by AI
Could you elaborate on the potential risks of alpha beta depletion for those receiving treatment?
"Despite the fact that there is no evidence of efficacy, alpha beta depletion's safety was evaluated as a 2 due to limited clinical data demonstrating its security."
Answered by AI
Is this research endeavor actively seeking participants?
"Clinicaltrials.gov shows that this experiment is still searching for participants since its initial post on April 1st 2021 and subsequent revision dated September 27th 2022."
Answered by AI
How many research participants are taking part in this investigation?
"Affirmative. Clinicaltrials.gov displays that this medical trial, initially posted on April 1st 2021, is currently enrolling participants. There is a requirement for 20 individuals at one facility to join the study."
Answered by AI
Is the upper age limit of 55 applicable to participants in this scientific trial?
"This trial only considers patients between one day and thirty years of age. Additionally, there are 586 clinical trials that focus on minors and 1979 studies for senior citizens."
Answered by AI
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