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This policy replaces the documents from 2020-03-24 and 2020-04-14
 
 
Dear valued partners,

Since mid of March 2020, cryopreservation of stem cell products to allow start of recipient’s conditioning only after safe arrival of the product, has become worldwide routine. Despite initial concerns, the impact of COVID-19 on availability of German DKMS donors was almost negligible, and most of the very few cases date back to March. On the contrary, general donor availability has even slightly improved compared to the 1st quarter of 2020, which we attribute to the general ‘lockdown’ measures. Especially travelling is a major contributor to unavailability under normal circumstances. For most regions currently, the transport situation has largely improved. Collection capacity for PBSC has never been really critical; BM collection and unstimulated leukapheresis capacities are back to normal. In addition, there is no evidence for transfusion-transmitted SARS-CoV2 infection.

We thus consider the updated NMDP or REDMO recommendations fully applicable for donors from our centers.

On the other hand, we are aware of 16 products that will never be infused, and another 10 where an infusion is extremely unlikely. The prevalent reasons are deterioration of recipient status and other patient related causes, though damage to the cells due to cryopreservation also plays a role. For 63 products currently, no plans for infusion can be provided or transplantation had to be re-scheduled. Considering we have received no confirmation of transplantation for another 53 cryopreserved stem cell products with a scheduled infusion until the end of June, we are highly concerned that up to 10% of all products will never benefit a recipient in need. This situation is clearly untenable for volunteer stem cell donations.

For mitigation purposes, we have re-assessed our cryopreservation policies.

DKMS does no longer recommend cryopreservation where transport to the transplant unit is considered safe (currently domestic, most of Europe, North America). If local infection rates change, we will adapt accordingly.

We still will not generally refuse COVID-based cryopreservation requests from such regions. However, for successful evaluation the criteria below must be met:

• BM cryopreservation will only be accepted if excess cell counts can be expected (e.g., for small children)

• Conditioning must be planned as soon as possible after the product arrives. That is, within days (unless local jurisdiction requires certain quarantine periods). Please provide the scheduled dates for start of conditioning and for infusion with the request.

• The transplant center must assess and confirm recipient’s eligibility for immediate transplantation before scheduled start of the donation procedure, i.e. the 1st dose of GCSF or hospital admission for BM collection. This assessment must include:

o Recent health status
o Patient’s extended and verification typing
o Insurance covering or other financial resources for transplant expenses
o Capacity in the TC

If this information has not been provided before start of mobilization, the collection unit, donor center, or the donor might decide to terminate/abort/cancel the collection

• Any postponement of planned conditioning / infusion dates must be communicated in a timely manner and may result in also postponing the collection, as would be the case with non-cryopreserved products.
 
We apologize for additional workload, but unfortunately all requirements stem from actual incidents. Providing this information as early as possible, together with the cryopreservation request will save critical time.

Best wishes,

Your DKMS Team 
 
 
 
 
 
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DKMS gemeinnuetzige GmbH
Kressbach 1
72072 Tuebingen
Germany

dkms.de
news@dkms.de

T +49 70 71 9 43-0
F +49 70 71 9 43-1499

Managing Directors: Dr. Elke Neujahr, Sirko Geist, Dr. Dr. Alexander Schmidt
Commercial Registry: Commercial registry department B of the local court Stuttgart HRB 381293