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Single Treatment With FT1050 of an Ex-vivo Modulated Umbilical Cord Blood Unit

NCT01527838 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-09-12

No results posted yet for this study

Summary

This trial is a prospective, open-label, single-arm trial of the safety of a single FT1050-treated CB unit for hematopoietic reconstitution after a reduced-intensity conditioning regimen for hematologic malignancies. A maximum of 40 eligible adult subjects will be enrolled and treated in the trial at approximately 2-4 centers within the U.S.

Conditions

  • Non-Hodgkin's Lymphoma (NHL)
  • Hodgkin's Disease
  • Chronic Lymphocytic Leukemia (CLL)
  • Acute Myelogenous Leukemia (AML)
  • Acute Lymphoblastic Leukemia (ALL)

Interventions

BIOLOGICAL

Single FT1050 treated UCB unit

Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood

Sponsors & Collaborators

Principal Investigators

  • Samuel Dychter, MD · Fate Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-10-31
Completion
2013-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01527838 on ClinicalTrials.gov