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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
Study Summary
This trial is testing whether a new way to prepare stem cells for transplantation will be safe and reduce the risk of complications.
Eligible Conditions
- Graft-versus-Host Disease
- Hematopoietic Stem Cell Transplant
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 1 year post-transplantation of apograft product
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 1 year post-transplantation of apograft product
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of ApoGraft as measured by adverse events related to ApoGraft product
Secondary outcome measures
Cumulative incidence of graft failure
Incidence of Grade 2-4 acute GVHD
Incidence of Grade 3-4 acute GVHD
+7 moreTrial 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
1,945 Previous Clinical Trials
2,304,559 Total Patients Enrolled
Zhifu Xiang, M.D.Principal InvestigatorWashington University School of Medicine
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