Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: CliniMACS CD34 Reagent for Myeloid Chimerism

Background: Sickle cell disease can often be treated with blood stem cell transplants. This study will give a second transplant to people whose disease has returned but still have some donor cells in their body.

Official registry: https://clinicaltrials.gov/study/NCT04008368 · National Heart, Lung, and Blood Institute (NHLBI) · enrollment listed as 32

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CliniMACS CD34 Reagent. The registry lists allocation as randomized. Background: Sickle cell disease can often be treated with blood stem cell transplants.

They plan to enroll about 32 people at Bethesda. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease or Beta-Thalassemia and Falling Donor Myeloid Chimerism Levels

Interventions: CliniMACS CD34 Reagent

Primary outcome (registry wording): dichotomous positive/negative outcome where a positive response is defined by absence of graft rejection

Who it is for (from inclusion criteria)

  • Ages 2 Years to 80 Years
  • who can join- recipient
  • Patient with history of SCD or beta thalassemia who previously underwent allogeneic hematopoietic stem cell transplantation (HSCT)
  • Persistent donor chimerism levels
  • Age greater than or equal to 4 years
  • Ejection fraction greater than or equal to 35%
  • DLCO greater than or equal to 35% (Note: This criterion may be omitted in young children (e.g. near the age of 5 years old) or other individuals who may have difficulty understanding or complying with the instructions for accurate testing.)

Public study contact (from the registry)

Julia M Varga, R.N.

(301) 402-3595

julia.varga@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT04008368 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04008368?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04008368?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary