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NCT00596999 Clinical Trial

A Single-arm Safety Study of Transplantation Using Umbilical Cord Blood and Human Placental-derived Stem Cells From Partially Matched Related Donors in Persons With Certain Malignant Blood Diseases and Non-malignant Disorders

Hematologic Malignancies Clinical Trial

— HPDSC  

Official title:
A Single-Arm Study to Assess the Safety of Transplantation With Umbilical Cord Blood Augmented With Human Placental-Derived Stem Cells From Partially Matched Related Donors in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00596999
Other study ID # CCT-HPDSC-001
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received January 8, 2008
Last updated April 9, 2012
Start date May 2007
Est. completion date December 2013

Study information
Verified date November 2007
Source Celgene
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

To investigate the safety of partially matched related human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells from the same donor in subjects with various malignant or nonmalignant disorders potentially curable with stem cell transplantation and to assess potential restoration of normal hematopoiesis and immune function in subjects with these disorders

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 6
Est. completion date December 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 55 Years
Eligibility Inclusion Criteria:

- suitable UCB collected from partially or fully HLA matched related donor

- subject requires umbilical cord transplantation

Exclusion Criteria:

- any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

- major anticipated illness or organ failure incompatible with survival from stem cell transplant

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• UCB and HPDSC
single dose of UCB followed by one unit of HPDSC

Locations
Country Name City State
United States Louisiana State University Children's Hospital New Orleans Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of GVHD, time to engraftment and survival 2 years Yes
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