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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

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

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 more

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)

Do I qualify?Apply below to find out

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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

1,931 Previous Clinical Trials

2,299,705 Total Patients Enrolled

Zhifu Xiang, M.D.Principal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the ApoGraft device been granted sanction by the Food and Drug Administration?

"ApoGraft's safety rating is 1 due to the limited data indicating its efficacy and safety, as this a Phase 1 trial."

Answered by AI

Who is eligible to take part in this experiment?

"36 adults of ages 18 to 70 that have hematopoietic stem cells are being accepted into this medical trial. The primary criteria for enrollment includes: gender (male or female), age range (18-70) and a performance score of 0-1 on the ECOG scale at screening."

Answered by AI

Is enrollment for this trial open to the public at this time?

"Clinicaltrials.gov reports that the trial is still enrolling participants, which began on December 16th 2020 and was most recently amended July 12th 2022."

Answered by AI

Are octogenarians able to participate in this clinical investigation?

"The eligibility requirements for this clinical trial specify that in order to participate, patients must be aged 18 or over and no older than 70."

Answered by AI

How many individuals are being recruited for this medical research?

"Affirmative, the information on clinicaltrials.gov demonstrates that this medical experiment is actively recruiting volunteers. This trial was initially announced on December 16th 2020 and was most recently updated on July 12th 2022. The project needs to enroll 36 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ApoGraft for the Prevention of Acute Graft Versus Host Disease in Haploidentical Hematopoietic Cell Transplant Recipients

2020. "ApoGraft for the Prevention of Acute Graft Versus Host Disease in Haploidentical Hematopoietic Cell Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04006652.