Status:

COMPLETED

Blood Cell Collection for Future Use in Individuals With Fanconi Anemia

Lead Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsors:

Children's Hospital Medical Center, Cincinnati

Conditions:

Fanconi Anemia

Eligibility:

All Genders

1-35 years

Phase:

NA

Brief Summary

Fanconi anemia (FA) is a disease that affects an individual's bone marrow. It is caused by a defective gene in the CD34+ cells, which are responsible for producing various types of blood cells. Indivi...

Detailed Description

FA is a rare, inherited disease that is caused by a gene defect to the CD34+ cells. It primarily affects an individual's bone marrow, resulting in decreased production of blood cells. The lack of whit...

Eligibility Criteria

Inclusion

  • Diagnosis of FA
  • Normal bone marrow cytogenetics within 3 months of study entry
  • Absolute neutrophil count (ANC) level greater than 750
  • Hemoglobin level greater than 8 without transfusion
  • Platelet level greater than 30,000 without transfusion
  • Must weigh at least 7.5 kg

Exclusion

  • Myloid or lymphoid leukemia
  • Cytogenic abnormalities
  • HIV infected
  • Neoplastic or non-neoplastic disease of any major organ system that would compromise the ability to withstand the collection procedure
  • Uncontrolled infection
  • Unable to tolerate general anesthesia
  • Known adverse reaction to E. Coli
  • Pregnant or breastfeeding

Key Trial Info

Start Date :

August 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2007

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00271089

Start Date

August 1 2004

End Date

October 1 2007

Last Update

July 12 2016

Active Locations (1)

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1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229