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Quality Control in HSCT and Donor Registries

Joint accreditation committee ISCT (international society for cellular therapy) and EBMT (JACIE)

  • JACIE is a non-Profit organization established for the purpose of assessment and accreditation in the field of HSCT.
  • Established in 1998.
  • Modeled on US based-Foundation for the accreditation of cellular therapy (FACT)
  • Joint FACT-JACIE standards are applicable internationally.
  • External inspectors carry out check compliance. Inspector should undergoJACIE sponsored training course and pass the exam.
  • Accreditation is voluntary process.
  • Several countries and competent authorities have included JACIE accreditation as a requisite for authorization of transplant program or for reimbursement of transplant cost.(They include Netherlands, Switzerland, France and Italy)

 

FACT-JACIE Standards-Cover all aspects of clinical transplant program.

  • Bone marrow and PBSC harvest and processing 
  • Therapeutic use of HSC, donor lymphocytes and mesenchyme stem cells.
  • Clinical use of cord blood units.

Standards with detailed guidance are published in the form of manual

 

General aspects of standards

  • Documentation of policies, procedures, actions, requests and so on.

Ex: Evaluation of donor as per the format to know eligibility.

  • Personnel involved must be appropriately qualified.
  • Validation of all equipments and procedures.

 

Donor Registries

  • Because of small families matched sibling donors are available to only 1/3rd patients.
  • >50% patients’ fate is dependent on international collaboration.
  • NMDP registers 25,500 new donors each month and has >8 million donors.
  • Functions of registry
    • Collects data from all inventories into single file and maintains adequate IT and administrative infrastructure.
    • Provides list of donors to requesting organizations.
    • Manages flow of information
    • Takes care of related invoices and payments.

 

Search unit

  • Triggers all actions aiming at identification of suitable MUD or Cord blood unit.

 

Functions of donor centre.

  • Recruits new donors (Does publicity if required)
  • Informed consent of interested volunteers.
  • Registers relevant data of donors (Age, gender, CMV status, blood group, previous pregnancies)
  • Gets back at reasonable intervals to keep them motivated and contactable, when they are needed.
  • Collects PBSC/BMSC 

 

Unrelated donor search(Includes MUD and CBU)

  • BMDW must be consulted, only if identifying donor in national registry fails.
  • Once donor has been identified , his blood is sent to search unit, for confirmation of all tests (Verification typing and extended typing)

 

Bone marrow donors worldwide (BMDW)

  • Maintains database of HLA phenotypes of adult unrelated donors and CBU from practically all registries, available for international transplants.
  • Operated by Dutch registry, Europdonor, in Leiden.
  • In 2011, 66 registries from 47 countries and 48 Cord blood banks from 28 countries were included (Total of 17.5million donors)
  • Access to this data is via password protected search tool on the web
  • Provides lists of matched or acceptably mismatched MUDs or CBUs based on patient’s HLA phenotype.
  • Access is granted to all persons/ institutions involved in donor searches.
  • More details are available at -www.bmdw.org

 

European marrow donor information system (EMDIS)

  • Network connecting computer systems of 26 registries on 5 continents.
  • EMDIS broadcasts data of every new patient requiring transplant, to all its registries.

 

Recent advances:

Automating outcome analysis after stem cell transplantation: The YORT tool

The Yearly Outcome Review Tool (YORT) was developed to streamline the analysis of hematopoietic stem cell transplantation outcomes, reducing the workload and enhancing standardization. YORT extracts data from a single-center EBMT registry export, enabling users to define filters and groups for specific analyses. It automates standardized assessments for overall survival, event-free survival, engraftment, relapse rate, non-relapse mortality, complications (including Graft vs Host Disease), and data completeness. YORT also allows data to be exported for manual analysis. This tool was demonstrated using a two-year single-center pediatric cohort, illustrating how it visualizes results for survival and engraftment. YORT simplifies outcome reviews, aiding in local and accreditation purposes with minimal effort and accommodating future changes and extensions.

https://doi.org/10.1038/s41409-023-02009-0

 

Nutrition support and clinical outcomes following allogeneic stem cell transplantation 

A retrospective study compared enteral nutrition (EN) to parenteral nutrition (PN) in patients undergoing allogeneic stem cell transplantation (SCT). Patients receiving EN followed by a switch to PN had longer hospital stays, while those receiving EN exclusively had shorter stays. Patients receiving EN, whether switched to PN or not, also had faster neutrophil and platelet engraftment compared to those receiving PN only. This suggests that EN should be the primary choice for nutritional support in allogeneic SCT patients. 

https://doi.org/10.1038/s41409-023-02080-7

 

Artificial intelligence methods to estimate overall mortality and non-relapse mortality following allogeneic HCT

The study aimed to develop a new prognostic score for overall mortality (OM) in adult patients undergoing allogeneic hematopoietic cell transplantation (alloHCT), using data from the EBMT registry between 2010 and 2019. Additionally, the study sought to predict non-relapse mortality (NRM) using the developed OM score. Artificial intelligence techniques were employed, and the top models selected were "gradient boosting" for OM and "elasticnet" for NRM. The final prognostic model effectively stratified the risk of OM and NRM, demonstrating varying outcomes based on the assigned score. While the developed score provides valuable risk stratification, future prognostic models may benefit from incorporating additional biological or dynamic markers post alloHCT to further improve mortality prediction.

https://doi.org/10.1038/s41409-023-02147-5

 

 

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