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Cell Therapy

Stem Cell Transplant for Sickle Cell Disease (HaploSCD Trial)

Phase 2

Waitlist Available

Led By Mitchell S Cairo, MD

Research Sponsored by New York Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must demonstrate one or more of the following Sickle Cell Disease Complications: Clinically significant neurologic event (stroke) or any neurologic deficit lasting >24 hours that is accompanied by an infarct on cerebral MRI

Recurrent painful events (at least 3 in the 2 years prior to enrollment).

Must not have

Clinically significant fibrosis or cirrhosis of the liver

Females who are pregnant or breast-feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Summary

This trial is studying a high-dose chemotherapy regimen followed by an infusion of stem cells from a partially matched adult family member donor in treating patients with sickle cell disease.

Who is the study for?

This trial is for high-risk sickle cell disease patients who've had multiple painful events, adequate organ function, and specific complications like stroke or acute chest syndrome. They need a partially matched family donor and can't be pregnant, breastfeeding, non-compliant with medical care, have significant liver fibrosis/cirrhosis or previous stem cell transplants.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of high-dose chemotherapy followed by an infusion of immune cells from a family member to manage sickle cell disease. It aims to see if this approach offers long-term control over the condition.See study design

What are the potential side effects?

Potential side effects may include reactions to the transplant such as graft-versus-host disease (where donated cells attack your body), infection risks due to weakened immunity from chemotherapy, and typical chemo-related issues like nausea or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a stroke or brain injury related to my sickle cell disease.

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I have had at least 3 painful episodes in the last 2 years.

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My donor is a family member who does not have sickle cell disease.

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I can do most activities but may need help.

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I need regular blood transfusions due to an abnormal TCD test.

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I have sickle cell disease or Hemoglobin S Beta thalassemia.

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I have had at least two episodes of severe chest pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver scarring.

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I am not pregnant or breastfeeding.

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I have a family member who matches my HLA type and is willing to donate.

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I have had a stem cell transplant before.

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I have sickle cell disease with an untreated infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment related events

Secondary outcome measures

Health-related quality of life

Pulmonary/pulmonary vascular status

neurological/neurocognitive status

Trial Design

1Treatment groups

Experimental Treatment

Group I: Haplo Stem Cell TransplantationExperimental Treatment1 Intervention

CD34 selected T-cell depleted allogeneic SCT

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Miltenyi Biomedicine GmbHIndustry Sponsor

34 Previous Clinical Trials

1,625 Total Patients Enrolled

Ann & Robert H Lurie Children's Hospital of ChicagoOTHER

261 Previous Clinical Trials

5,189,377 Total Patients Enrolled

Washington University School of MedicineOTHER

1,949 Previous Clinical Trials

2,307,537 Total Patients Enrolled

Media Library

CD34 selected T-cell depleted allogeneic SCT (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01461837 — Phase 2

Sickle Cell Disease Research Study Groups: Haplo Stem Cell Transplantation

Sickle Cell Disease Clinical Trial 2023: CD34 selected T-cell depleted allogeneic SCT Highlights & Side Effects. Trial Name: NCT01461837 — Phase 2

CD34 selected T-cell depleted allogeneic SCT (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01461837 — Phase 2

~1 spots leftby Dec 2024

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