Status:
COMPLETED
Healthy Donor Study II - Comparing Plerixafor With G-CSF and Plerixafor
Lead Sponsor:
Stephen Couban
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Malignant Lymphoma, Stem Cell Type
Eligibility:
All Genders
18-30 years
Phase:
PHASE2
Brief Summary
Stem cells can be transplanted from a healthy donor to a patient to combat blood cancers and other disorders. This process is called stem cell transplantation. Stem cells normally live in the bone mar...
Detailed Description
Background: Stem cell transplantation (SCT) involves transfusing stem cells collected from 3 potential sources: bone marrow, peripheral blood, or umbilical cord. There are 2 major types of transplant...
Eligibility Criteria
Inclusion
- The inclusion and exclusion criteria are designed to reflect those that are used in practice to choose appropriate normal healthy donors for allogeneic stem cell transplantation.
- Male or female between the ages of 18 and 30
- Unable or unwilling to give written informed consent
- No history of cardiac, pulmonary, liver or renal disease
- Normal CBC, creatinine, liver enzymes, bilirubin, INR and PTT
Exclusion
- Allergy to G or to E.coli-derived agents
- Allergy to "caine" type anesthetics
- Pregnancy or breast feeding
- BMI greater than 25 to avoid difficulty with the number of bone marrows performed
- Skin conditions, autoimmune disease, sickle cell disease or splenomegaly to avoid rare side effects of G-CSF
- Any subject, who in the opinion of the investigator, should not participate in this study
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01403896
Start Date
April 1 2012
End Date
December 1 2015
Last Update
August 2 2017
Active Locations (1)
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1
Capital Health District Authority
Halifax, Nova Scotia, Canada