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ApoGraft for Graft-versus-Host Disease

Phase 1
Waitlist Available
Led By Zhifu Xiang, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 1 year post-transplantation of apograft product
Awards & highlights
No Placebo-Only Group

Summary

This trial tests ApoGraft, a method to prepare donor stem cells by removing harmful immune cells. It aims to help patients needing urgent stem cell transplants from half-matched family donors. The goal is to reduce complications like Graft versus Host Disease while still fighting leukemia.

Eligible Conditions
  • Graft-versus-Host Disease
  • Hematopoietic Stem Cell Transplant

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1 year post-transplantation of apograft product
This trial's timeline: 3 weeks for screening, Varies for treatment, and through 1 year post-transplantation of apograft product for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of ApoGraft as measured by adverse events related to ApoGraft product
Secondary study objectives
Cumulative incidence of graft failure
Incidence of Grade 2-4 acute GVHD
Incidence of Grade 3-4 acute GVHD
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RecipientExperimental Treatment1 Intervention
* Will undergo institutionally standard myeloablative or reduced intensity chemotherapy or chemoradiotherapy which will be administered at the discretion of the treating physician * Recipients will undergo a single fresh ApoGraft transplant as per standard clinical site guidelines
Group II: DonorActive Control1 Intervention
-Donors will undergo apheresis from peripheral blood after daily G-CSF administration (for up to 5 days prior to Day -1)

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cellect BiotechnologyIndustry Sponsor
2 Previous Clinical Trials
24 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,989 Previous Clinical Trials
2,295,814 Total Patients Enrolled
Zhifu Xiang, M.D.Principal InvestigatorWashington University School of Medicine
~1 spots leftby Nov 2025
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