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Stem Cell Transplantation
Umbilical Cord Blood Transplant for Aplastic Anemia and Myelodysplastic Syndrome
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
The CBU will have undergone volume reduction (both plasma and red blood cell depletion) prior to cryopreservation. All CBUs should be procured from public banks that meet local applicable regulations
Diagnosed with severe aplastic anemia with bone marrow cellularity <30% (excluding lymphocytes) associated with RBC or platelet transfusion dependence and/or neutropenia (absolute neutrophil count <=1000 cells/ uL or for patients receiving granulocyte transfusions, absolute neutrophil count <=1000 cells/ uL before beginning granulocyte transfusions)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 100 day and 200 day
Awards & highlights
Study Summary
This trial is testing if treating people with SAA or MDS with a co-infusion of blood stem cells from a family member and cord blood stem cells from an unrelated donor is safe and effective.
Who is the study for?
This trial is for people aged 4-60 with severe aplastic anemia or myelodysplastic syndrome (MDS) who haven't responded to standard treatments. They need a matching cord blood unit and must understand the study's nature. Excluded are those with certain heart, kidney, liver conditions, active infections, other cancers within 5 years, specific allergies, HIV positive status or if they're pregnant.Check my eligibility
What is being tested?
The trial tests a new treatment method using Omidubicel (formerly CordIn), which involves co-infusing stem cells from both a family member and unrelated donor cord blood to improve bone marrow transplant outcomes in patients with SAA or MDS.See study design
What are the potential side effects?
Potential side effects may include reactions related to chemotherapy and radiation such as nausea, fatigue, infection risk increase due to immune suppression; complications from the stem cell infusion like graft-versus-host disease; and organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cord blood unit was processed and stored according to required standards.
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I have severe aplastic anemia, need regular blood or platelet transfusions, and have very low neutrophil counts.
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My severe aplastic anemia has turned into MDS with specific risk and bone marrow cellularity.
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I did not respond well to standard immune system treatments.
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My cord blood unit meets the required cell count criteria.
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I have a cord blood match of at least 4/8 HLA types from the NMDP.
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I am between the ages of 4 and 60.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 100 day and 200 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~100 day and 200 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cord engraftment
Secondary outcome measures
Treatment related mortality (TRM), and standard transplant outcome variables such as non-hematologic toxicity, incidence and severity of acute and chronic GVHD, and relapse of disease
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment2 Interventions
CordIn is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,835 Previous Clinical Trials
47,310,605 Total Patients Enrolled
11 Trials studying Aplastic Anemia
922 Patients Enrolled for Aplastic Anemia
Richard W Childs, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
18 Previous Clinical Trials
8,719 Total Patients Enrolled
1 Trials studying Aplastic Anemia
500 Patients Enrolled for Aplastic Anemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cord blood unit was processed and stored according to required standards.My lung's ability to transfer gas is less than 40% of what's expected.I have a history of cancer that could come back or get worse within 5 years.My cord blood unit meets specific cell count criteria and has approval from Gamida Cell.I understand this study is experimental and I (or my guardian) can consent.I did not respond well to standard immune system treatments.I need some help with my daily activities.I have severe aplastic anemia, need regular blood or platelet transfusions, and have very low neutrophil counts.I do not have any major illnesses that would prevent me from surviving a transplant.My severe aplastic anemia has turned into MDS with specific risk and bone marrow cellularity.I have a matched donor or umbilical cord blood available for a transplant if needed.I have a relative who is a complete or near-complete match for stem cell donation.My kidney function is reduced, with a creatinine clearance rate below 50.My cord blood unit meets the required cell count criteria.You are allergic to cows, gentamicin, or any other product that might affect the treatment.I am eligible for a stem cell transplant with a perfect match donor.I have been diagnosed with Fanconi anemia.I have antibodies against the donor for my stem cell transplant.I have an infection that isn't getting better with treatment.I have a cord blood match of at least 4/8 HLA types from the NMDP.I am between the ages of 4 and 60.
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.
Is the eligibility threshold for this clinical trial limited to those aged 20 and under?
"This trial has recruited participants of all ages, from 4 years old to 75."
Answered by AI
Are there any openings in this trial available to participants?
"According to the clinicaltrials.gov listing, this medical trial is currently within its recruitment phase and has been available since June 13th 2017 with a most recent update taking place on November 2nd 2022."
Answered by AI
What is the scope of this investigation in terms of participants?
"Affirmative, the clinicaltrials.gov database indicates that this investigation is actively accepting participants. Initially posted on June 13th 2017 and last updated on November 2nd 2022, it seeks to recruit 37 subjects from one medical centre."
Answered by AI
Is it feasible to become involved in this experiment?
"This particular clinical trial is searching for 37 participants aged between 4 and 75 that have been diagnosed with anemia or aplastic anemia. To be eligible, these individuals must also fulfill several criteria: possess at least one HLA-matched cord blood unit from the National Marrow Donor Program; display transfusion dependence due to low bone marrow cellularity; show intolerance of standard immunosuppressive therapies; identify either another donor or umbilical cord blood units as backup options in case their own CordIn unit gets rejected; range between ages 4 and 60 years old (with parental/guardian consent being required if they are under 18"
Answered by AI
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