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

NCT ID: NCT00596999

Last Updated: 2012-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2013-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Hematologic Malignancies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

all subjects will be treated with UCB and HPDSC

UCB and HPDSC

Intervention Type PROCEDURE

single dose of UCB followed by one unit of HPDSC

Interventions

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UCB and HPDSC

single dose of UCB followed by one unit of HPDSC

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lolie Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Children's Hospital

Locations

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Louisiana State University Children's Hospital

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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CCT-HPDSC-001

Identifier Type: -

Identifier Source: org_study_id

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