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Stem Cell Transplantation
Stem Cell Transplant for Bone Marrow Failure Syndrome (ExpMACs Trial)
Phase < 1
Recruiting
Led By Nancy J Bunin, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with organ function criteria including Lansky or Karnofsky performance ≥60, serum creatinine ≤3xupper limit of normal for age, hepatic transaminases ≤10xnormal, cardiac shortening fraction ≥27%, bilirubin <2.5x normal (unless elevation due to Gilberts disease), and no active untreated infection
Patients with malignant diseases including acute leukemias, chronic leukemias, lymphomas, and myelodyplastic syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
ExpMACs Trial Summary
This trial is for children with a serious disease who are not eligible for other stem cell transplant protocols. The goal is to expand access for patients who lack a fully HLA matched sibling donor.
Who is the study for?
This trial is for patients without a fully matched sibling donor who need a stem cell transplant due to serious conditions like leukemia, metabolic diseases correctable by HSCT, bone marrow failure, or immune system problems. They must meet specific health criteria and not be pregnant or have uncontrolled infections.Check my eligibility
What is being tested?
The trial provides access to a special stem cell transplant using CliniMACs technology to deplete certain cells (CD3+/CD19+) from the donated material. It's aimed at those who can't participate in other trials but need this potentially life-saving procedure.See study design
What are the potential side effects?
While specific side effects are not listed here, stem cell transplants can generally cause reactions such as fatigue, infection risk increase due to immune suppression, graft-versus-host disease where the new cells attack the body, and organ complications.
ExpMACs Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My organ functions meet the required levels, and I don't have an untreated infection.
Select...
I have a type of blood cancer such as leukemia, lymphoma, or myelodysplastic syndrome.
Select...
I have a non-cancerous condition treatable by stem cell transplant.
ExpMACs Trial 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
Overall Survival
Secondary outcome measures
Graft Failure
Graft versus Host Disease
ExpMACs Trial Design
1Treatment groups
Experimental Treatment
Group I: Expanded access to CliniMACs device for T cell depletionExperimental Treatment1 Intervention
access for patients who lack a fully HLA matched sibling, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-open protocols that utilize CliniMACs technology for T depletion. Subjects will undergo transplant of stem cells with CD3+/CD19+ depletion.
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,580,959 Total Patients Enrolled
15 Trials studying Leukemia
1,380 Patients Enrolled for Leukemia
Nancy J Bunin, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
3 Previous Clinical Trials
253 Total Patients Enrolled
1 Trials studying Leukemia
140 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My donor cannot give stem cells through their bloodstream.My organ functions meet the required levels, and I don't have an untreated infection.I am currently pregnant.I do not have any ongoing serious infections.You don't have a fully matched sibling for a specific type of stem cell transplant, and you don't meet the requirements for other treatment options at the hospital.I am capable of becoming pregnant and have a negative pregnancy test.I have a type of blood cancer such as leukemia, lymphoma, or myelodysplastic syndrome.I have a sibling donor who is a complete HLA match.I have a non-cancerous condition treatable by stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Expanded access to CliniMACs device for T cell depletion
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.
What is the capacity for enrolling participants into this research endeavor?
"Indeed, the clinicaltrials.gov portal confirms that this trial is presently recruiting participants. Originally posted on December 1st 2013 and last updated November 8th 2022, a total of 100 patients are needed from one site to complete the study."
Answered by AI
Are new participants accepted into this research endeavor?
"Affirmative. The data hosted by clinicaltrials.gov demonstrates that this experiment is presently recruiting participants, which was first posted on December 1st 2013 and updated most recently November 8th 2022. A hundred subjects are required from a single site for the trial to be successful."
Answered by AI
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