Blood Cell Collection for Future Use in Individuals With Fanconi Anemia

Plain-language summary

This study examines the collection of blood stem cells and bone marrow cells from individuals with Fanconi anemia for future use. It enrolled individuals diagnosed with Fanconi anemia who had normal bone marrow findings and met certain blood values. The research was conducted as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Intervention

PBSC Collection, Bone Marrow Harvest, CliniMacs Cell Selection System

Start date

8/1/2004

Estimated completion

10/1/2007

Countries

United States

Related genes

Locations

• Cincinnati, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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 Criteria:

* 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