Post Graduate Institute of Child Health (PGICH), Noida, India Delhi, Delhi, India
Background/Case Studies: Hematopoietic stem cell transplants (HSCT) are increasingly been offered to patients for various conditions in India. Indian stem cell transplant registry (ISCTR) shows that a total of 2,533 transplants were done in India (2019). The concept and indication of HSC manipulations (minimal) are very well explained in the recent guidelines by the Indian Council of Medical Research (ICMR) however the recommended methods and release criteria are still not uniform in India.
Study
Design/Methods: An epidemiological descriptive cross-sectional survey (55 questions) of the centre providing HSCT in India was planned to capture the reporting centre's demographic details as well as variations in their policies and practices of HSCT graft minimal manipulation (plasma reduction, RBC depletion and cryopreservation).
Results/Findings: Sixty-four centres responded to the survey (63/102; response rate: 62.7%) and majorly from the Northern part of India (27 out of 63; 42.1%). The majority of reporting centres reported performing >50 HSCTs annually (n=24; 39%) and 92% (58 out of 63) of the reporting centres performed stem cell collections from a paediatric donor/ patient (age < 18 years). Minimal product manipulations were performed by 56 of 63 centres (more than one type of manipulation): cryopreservation (n=45), plasma reduction (n=42), and RBC depletion (n=28). Cryopreservation was primarily done by blood centres (60%, 27 of 45) with DMSO being the primary constituent with the most common concentration of 5-10% (62%; 28/45 centres) being used. “Dump freezing” (using -80ºC deep freezer) was the most common mode of freezing used (60%; 27/45 centres). “7AAD flow cytometry” based viability assessment was most commonly done (66%; 30/45 centres) post cryopreservation. Thawing of the product was done majorly at the bedside (66%; 30/45 centres) using majorly a “wet type” thawer (80%; 36/45 centres) and washing of DMSO was done by a few centres (15.5%; 7/45 centres). “Plasma reduction” and “RBC depletion” was primarily done for ABO incompatibility at blood centres. The majority of the centres were not performing isoagglutinin titres whereas the centres which perform titre considered a titre of >1:64 significant to do these RBC or plasma reduction. Quality control and release criteria after plasma reduction and RBC depletion were also not uniforms. Conclusions: This survey identifies the lack of standardization and uniformity in the minimal manipulation of HSC at labs with centres supporting HSCT in India. This work also highlights the need for more studies and country-specific recommendations to establish best practices for India.
Importance of research: This is one of the first data on the policies and practices in minimal manipulation of hematopoietic stem cells at cell therapy labs in India and highlights the need of country specific guidelines.
