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Stem Cell Therapy
CD34+ Stem Cell Selection for Bone Marrow Failure Syndromes
Phase 1 & 2
Waitlist Available
Led By Diane George, MD
Research Sponsored by Diane George
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be ≤ 40 years of age. Patients with sickle cell anemia must be at least 2 years of age.
Requirement for CD34+ stem cell selection for a second infusion of stem cells following an allogeneic stem cell transplant from a related or unrelated adult donor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing a new way to do stem cell transplants for people with non-cancerous diseases. They're testing how well it works and if it has any serious side effects.
Who is the study for?
This trial is for children, adolescents, and young adults with various non-malignant diseases like sickle cell anemia or immune deficiencies. Participants must be under 40 years old, have a matched family or unrelated adult donor for stem cells, and good organ function. Pregnant women and those with uncontrolled infections or certain complications from sickle cell anemia are excluded.Check my eligibility
What is being tested?
The study tests CD34 Stem Cell Selection Therapy in patients receiving allogeneic peripheral blood stem cell transplants. It aims to assess the treatment's impact on graft versus host disease, graft rejection, survival rates, immune system recovery timeframes, and infection incidences post-transplant.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may include risks of infection due to weakened immunity post-transplantation; reactions at the infusion site; potential organ inflammation; delayed marrow engraftment leading to prolonged hospitalization; and possible development of new autoimmune disorders.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or younger. If I have sickle cell anemia, I am at least 2 years old.
Select...
I need a second stem cell transplant from a donor.
Select...
I have a matched unrelated donor for my treatment.
Select...
My family donor matches me at least 50% for the transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of acute graft versus host disease (GVHD)
Secondary outcome measures
Incidence of infectious complications
Incidence of primary graft failure
Incidence of secondary graft failure
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CliniMACS PLUS followed by chemotherapyExperimental Treatment1 Intervention
Patients will receive a pre-transplant conditioning regimen of Busulfan Fludarabine and Alemtuzumab. For patients with pre-transplant hepatic dysfunction, Melphalan will be substituted for the Busulfan. For patients receiving a second transplant or a "boost", pre-transplant conditioning based on the clinical condition of the patient will be determined by the Principal Investigator and the patient's bone marrow transplantation (BMT) physician. The donor peripheral blood stem cells will undergo CD34+ selection (Biological/Vaccine: CD34 Stem Cell Selection Therapy). The CliniMACS (PLUS) Reagent System will be used to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic graft versus host disease (GVHD).
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Who is running the clinical trial?
Diane GeorgeLead Sponsor
1 Previous Clinical Trials
15 Total Patients Enrolled
Diane George, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
15 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have sickle cell anemia but no recent severe infections, HIV, or recent HCT.You have certain blood disorders as outlined in the study's guidelines.I do not have any untreated infections.I am 40 years old or younger. If I have sickle cell anemia, I am at least 2 years old.My kidneys, liver, heart, and lungs are all working well.I need a second stem cell transplant from a donor.My kidneys, liver, heart, and lungs are working well.My HLA type has been determined by detailed DNA testing.I have a matched unrelated donor for my treatment.I do not have any serious illnesses other than cancer.My family donor matches me at least 50% for the transplant.
Research Study Groups:
This trial has the following groups:- Group 1: CliniMACS PLUS followed by chemotherapy
Awards:
This trial has 1 awards, including:- 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.
Is there currently an effort to enroll participants in this research endeavor?
"As per the information posted on clinicaltrials.gov, this medical study is not presently seeking to enrol new candidates. The trial was first announced on March 1st 2013 and last updated on June 17th 2020; however there are currently 2528 other trials that participants may be interested in joining."
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