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Stem Cell Transplant
Cord Blood Transplant for Blood Cancers and Diseases
Phase 1 & 2
Recruiting
Led By Richard W Childs, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is for people who need cord blood transplants and best match cord blood units that are not FDA-licensed. Doctors will observe participants for up to a year after the transplant.
Who is the study for?
This trial is for pediatric and adult patients of any age with blood cancers or diseases affecting the bone marrow, like Myelodysplastic Syndrome or Aplastic Anemia. Participants must need a cord blood transplant and match with unlicensed cord blood units that meet NMDP standards but not current FDA standards.Check my eligibility
What is being tested?
The study is testing the use of unlicensed preserved cord blood units for transplants in individuals who require them. These cord blood units comply with National Marrow Donor Program standards but may fall short of newer FDA requirements.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks generally associated with cord blood transplants include infection, graft-versus-host disease, bleeding complications, and reactions to infused cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a blood disorder that is inherited, acquired, or caused by treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 days to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 days to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To examine the incidence of neutrophil recovery of greater than or equal to 500/mm3 after unlicensed CBU transplant.
Secondary outcome measures
Assess incidence of graft rejection, transmission of infection, serious infusion reactions. Determine 1 year survival. Assess cumulative incidence of acute GVHD (grades II to IV), (grades III to IV), and incidence of chronic GVHD.
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
cord blood transplant with unlicensed CBU
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,847 Previous Clinical Trials
47,818,026 Total Patients Enrolled
Richard W Childs, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
18 Previous Clinical Trials
8,256 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a blood disorder that is inherited, acquired, or caused by treatment.I am only receiving treatments approved by health authorities.I am of any age.
Research Study Groups:
This trial has the following groups:- Group 1: 1
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.
Which individuals are eligible to join this medical experiment?
"This clinical trial calls for 500 participants between the ages of 4 and 99 who are suffering from hematologic diseases."
Answered by AI
What is the enrollment cap for this medical experiment?
"Confirmed. The clinicaltrials.gov website states that this trial is recruiting participants; it was initially published on February 21st 2012 and its parameters were most recently edited on October 8th 2021. The study necessitates 500 patients be enrolled from one medical centre."
Answered by AI
Is the age requirement for enrolling in this clinical experiment above twenty years old?
"The participant criteria for this study necessitates that individuals should be between 4 and 99 years old."
Answered by AI
Is the window for enrollment in this trial still open?
"The clinical trial is actively recruiting, as per the data on clinicialtrials.gov. The study was initially advertised to prospective participants on February 21st 2012 and underwent its last update October 8th 2021."
Answered by AI
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