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Impact of COVID-19 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience

NCT05088941 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 89

Last updated 2022-07-22

No results posted yet for this study

Summary

the SARS-CoV2 pandemic has led to a major reorganization of the French Hematology and stem cell transplant departments since march 2020. Since the allogeneic stem cell transplant cannot be delayed especially when patients with hematological malignancies are in a fragile remission, risking relapse at any time, the necessity to maintain safe hematopoietic stem cell (HSC) donations from match unrelated or family donors appears rapidly mandatory during the pandemic period. To increase the safety of voluntary donations, a SARS-CoV2 Polymerase Chain Reaction test has been recommended to donors by regulatory agencies. However, due to the lack of homogeneity of care at European level, some countries do not require SARS-CoV-2 testing in asymptomatic donors. In this case, the test is performed on additional EDTA tube accompanying the graft on arrival or in the case of a missing tube (not collected or forgotten), on few milliliters of the HSC graft. This circuit had the consequence of forcing the clinicians to wait for the test result before starting the patient's conditioning regimen. The graft being already collected and received at the transplant center, and the conditioning regimen lasting on an average of 5 days, this resulted in its conservation during this minimum period and therefore its freezing by the associated cell therapy unit. However, this practice has so far been exceptional regarding allogeneic transplants, which are primarily freshly infused to ensure to the recipient the highest viability and functionality of stem cells. Since the entire freezing-thawing and washing process may impact cell viability and delay the patient's aplastic recovery, this study aimed to analyze the results of one year of allogeneic transplants infused after freezing in terms of graft quality after thawing and clinical consequences.

Conditions

  • Allogeneic Stem Cell Transplantation
  • SARS-CoV2 Infection
  • COVID-19

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-09-01
Completion
2021-09-02

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05088941 on ClinicalTrials.gov