Printed from Voxsanity (voxsanity.com.au) — NCT07015684 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Sickle Cell Disease
Phase 1 Sickle Cell Disease Trial, Recruiting
NCT07015684
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 have a brother or sister whose tissue type (HLA) closely matches yours and who could be a donor
- You have been diagnosed with sickle cell anemia (specifically Hb SS, Sβ0 thalassemia, or severe SC disease) and are between 12 and 50 years old
- You have had a stroke or a significant neurological problem (such as weakness or speech difficulties) lasting at least 24 hours, confirmed by a brain scan
- You have had two or more episodes of a serious lung complication called acute chest syndrome within the past 2 years, even while receiving treatment
- You have had three or more severe pain crises per year over the past 2 years, even while receiving treatment
- You have been receiving 8 or more blood transfusions per year for at least 1 year to prevent complications from sickle cell disease
- A heart scan (echocardiogram) has shown a specific measurement of blood flow through your heart valve at or above a certain level, or you have been diagnosed with high blood pressure in your lungs
- You have liver problems related to sickle cell disease, shown by specific blood test results (confirm with trial site)
- Your general health and ability to carry out daily activities meet a certain minimum standard (confirm with trial site)
- Your heart is pumping blood adequately, with the heart's pumping strength at 40% or above
- Your lungs are working well enough, with blood oxygen levels of 85% or above and lung function tests meeting a minimum level
- Your liver function blood tests are below a certain level of concern
- You do not have liver scarring (cirrhosis) or active liver inflammation, confirmed by a liver biopsy if needed
Who may not be able to join:
- Your lung function is too low, with oxygen levels below 85% or lung capacity below 40% of what is expected
- Your heart's pumping strength is below 35%
- Your kidneys are not working well enough (below a certain filtering rate)
- You have significant liver scarring or liver function blood tests that are too high
- You have had a stroke within the 6 months before the planned transplant
- Your overall ability to carry out daily activities is below a certain level (confirm with trial site)
- You are living with HIV
- You currently have an active infection (bacterial, viral, fungal, or parasitic) that is not under control
- You have certain antibodies in your blood detected during initial screening (confirm with trial site)
- You have previously received radiation to the maximum safe level on any important organ
- You have ongoing health problems serious enough that a stem cell transplant would be considered too risky
- You are not able to understand what the transplant procedure involves and its risks
- You have a history of not following medical treatment plans seriously enough that the medical team feels the transplant would not be safe or appropriate
- You are currently pregnant or breastfeeding
- There are concerns about your ability to receive blood transfusions safely, or you have antibodies in your blood that could react with your donor's stem cells
- You have any previous history of radiation therapy
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.
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Markus Y Mapara, MD, Columbia University
Phone: (212) 342 5162
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
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
28 April 2025
Est. completion
12 March 2030
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Graft failure rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.