Sickle Cell Disease Trial, Recruiting NCT05213572 Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Condition: Sickle Cell Disease
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Sickle Cell Disease Trial, Recruiting

NCT05213572
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to follow all study procedures and are available for the full length of the study.
  • You are 18 years old or older, of any gender.
  • You have been diagnosed with sickle cell disease (any type, including HbSS, HbSC, HbSβ0-thal, or HbSβ+-thal), and either plan to receive a stem cell transplant or gene therapy, OR are currently receiving other treatments and do not plan to have a transplant or gene therapy.
  • You are able to travel to the NIH Clinical Center for appointments.
  • You are able to read and understand a written consent form.
  • You meet at least one of the following conditions:
    • You have had a stroke or an abnormal brain blood flow test result (confirm with trial site)
    • You have kidney problems linked to sickle cell disease, based on specific lab results or a kidney biopsy (confirm with trial site)
    • You have a specific type of abnormal heart valve measurement found on an ultrasound (confirm with trial site)
    • You are male and have had at least 2 episodes of a painful, prolonged erection lasting over 4 hours
    • You have liver disease related to sickle cell disease, based on specific blood test results (confirm with trial site)
    • You have been hospitalised more than once per year for severe pain episodes while taking a full dose of hydroxyurea
    • You have had a serious lung complication called acute chest syndrome while taking a full dose of hydroxyurea
    • You have had bone damage in 2 or more joints
    • Your body has developed reactions against donated red blood cells (confirm with trial site)

Who may not be able to join:

  • You have previously had a transplant of any kind, including a stem cell or kidney transplant.
  • You are currently pregnant or breastfeeding.
  • You have an allergy to iodine or iodine-based contrast dyes — though you may still be able to participate in some parts of the study (confirm with trial site).
  • You have a metal implant in your body that is not safe for MRI scans, such as certain brain clips, cochlear implants, or pacemakers.
  • You have a pacemaker or an implanted heart device — though you may still be able to join and take part in some tests if your device is MRI-compatible (confirm with trial site).
  • You currently need peritoneal dialysis or haemodialysis (kidney dialysis).
  • You have an active, uncontrolled infection or are currently acutely ill.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Courtney F Joseph, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Phone: (301) 402-3595

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
24 March 2022
Est. completion
1 June 2035

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in LVEDV/BSA in patients with SCD who undergo curative therapies as compared to patients who receive non-curative treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov