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Leukapheresis Procedures on the GCRC — Investigator Timeline and Requirements
The GCRC offers a leukapheresis service so investigators may obtain peripheral blood
mononuclear cells in large quantities from human subjects for research or therapeutic
purposes. Subjects may be scheduled for the procedure after the investigator has a protocol
for the procedure approved by both the IRB and the GCRC Scientific Advisory Committee.
Apply to use the GCRC leukapheresis program
Each leukapheresis procedure will cost the investigator $400.00.
Leukaphereses are provided for GCRC investigators "at cost." The GCRC will provide the machine
and staff free of charge —the investigator will be charged for the cost of the
disposables for the procedure.
HOWEVER — if these leukaphereses are being obtained in context of a clinical trial that
utilizes the GCRC cGMP Gene and Cell Therapy Laboratory to produce
a therapeutic product, then all apheresis procedures needed to execute the study are provided
at no cost to the investigator.
To utilize the GCRC leukapheresis program you must go through the usual
GCRC application process and obtain approval from the Scientific Advisory Committee.
Once the request for apheresis has been approved by the SAC:
The investigator and or clinical research staff needs to meet
with the Nurse Manager (206-598-1913) to:
- Develop the apheresis orders
- Develop protocol-specific labelling SOP
- Review what the scheduling requirements will be for the protocol
Set up an AAA account
for research billing (for cost of disposables if not fully provided by the GCRC). Our
administrator can help (206-598-4701).
Provide the administrator with final copies of the following
documents:
- Approved final revised SAC application (we will provide)
- Documentation of HSD approval including a copy of the current consent form
- Copy of IND approved Certificate of Release and final product label if cell product is to be given to subjects on the GCRC
Schedule a Study Implementation Meeting (SIM)
more information
Please note — if the protocol does not have a treatment arm, i.e. is for specimen
collection only, then the SIM will be abbreviated.
Attendees will include the investigator and/or clinical staff designee, apheresis team, cGMP
Gene and Cell Therapy Laboratory Manager or staff designee, and the GCRC Nurse Manager or
Assistant Nurse Manager.
| Goals of the meeting |
- Finalize orders for the study
- Review of transport and processing of final product
- Establish emergency contacts
- Review roles and responsibilities of each team member
- Subject venous access
- Walk through a typical visit
- Evaluate equipment and supplies necessary to perform the study
- Review scheduling process
- Review documentation requirements of the GCRC
- Need copy of consent, HIPPA, eligibility checklist prior to seeing patient
- All IRB approvals, modifications, reports need to be cc'd to GCRC
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A copy of the minutes from the initiation meeting will be provided to you for your regulatory
file.
Once the study has started
Schedule the subject
Subjects must be screened prior to scheduling the
procedure. This can either be performed by the GCRC apheresis staff or by qualified personnel
working with the investigator. If the subject is considered able to undergo apheresis at the
GCRC using typical IV access then the subject can be scheduled. If the screening is not
performed by the GCRC staff, a note must be provided to the apheresis program by the off-site
screener documenting access.
What if my patient DOES NOT have adequate venous access?
more
The subject is scheduled for apheresis.
The study coordinator may email crcshed@u.washington.edu
with study-specific information and request an appointment for apheresis donor screening exam
and apheresis procedure.
Please note: some of our subjects must be apheresed
emergently for therapeutic purposes. These subjects are a priority in scheduling. If you have
a subject scheduled for a research collection only that person may have to be rescheduled if
an emergent therapeutic apheresis occurs. This occurrence is rare.
Informed consent obtained.
The following studies must be presented to the apheresis team on
the day of the procedure:
Leukapheresis History and Physical
Word
or
PDF
rev. 04/2005
- Hematocrit
- CBC with differential screening.
- If CBC was tested more than 72 hours prior to apheresis a STAT CBC will be done prior to apheresis.
- Virology testing.
- A blood sample is sent to the Puget Sound Blood Bank where a "recipient/patient battery" is run. Test results take 48-72 hours and the fee is $150.00.
- If test results are not finalized, but pending documentation is presented to the apheresis team, apheresis may be performed.
- Brief history and physical performed within 1 week of the procedure for patient donors
- The investigator may use a note generated in the clinic. We also provide a form that investigators may use that includes all necessary information to fulfill subject safety and other regulatory requirements.
Laboratory values are evaluated for patient safety
reasons and if adequate by protocol subject apheresis begins.
Product is collected and distributed or transported as
per the investigators SOP.
Subject is discharged from the unit.
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