• Jo-ann Tonon, ASCP SBB
    Acting Senior Manager, Transfusion Medicine and Cell Therapy Laboratory
    Center for Laboratory Medicine
    Memorial Sloan Kettering Cancer Center

    The COVID19 pandemic has created many challenges for Cell Therapy Processing laboratories. Some of our challenges have included:

    Staffing: absences, commuting difficulties, how to achieve some level of social distancing in the laboratory that is still operating during the pandemic. Our institution has provided reimbursement for travel, which has helped us to have our staff onsite. We divided the staff into 2 designated teams, working longer shifts but less days onsite with opposite schedules to reduce the incidence exposure. This also gave us the opportunity to assign and coordinate continuing education activities while off site by enabling remote connectivity.

    Restrictions and delays on the collection and  receipt of unrelated donor product through the NMDP: The NMDP request to cryopreserve all products added additional workload to staffing. Fortunately, our lab routinely freezes allogeneic products using a well validated procedure, so the impact was minimal.  

    Supply issues: Cryo bags and  Proper Protective Equipment.  As part of our  institution’s emergency response team, designated supply chain resources were able to contact  manufacturers directly to obtain supplies and to follow up on back orders, relieving the laboratory staff of that duty. By reexamining our procedures to avoid waste while maintaining safe practices, we were able to conserve mask and lab coat supplies

    Facility restrictions: Restriction on vendors on site and the  receipt of deliveries from NMDP, was a challenge. Each vendor had their own restrictions (travel restrictions, questionnaire requirements) as well as the institutional requirements. International NMDP couriers were restricted full access, so that lab staff had to perform the hand off outside the confines of the laboratory. Staff worked with manufacturers via WebEx and Zoom to perform Preventative Maintenance activities that were due.

    Protocol activity: Restrictions on qualification audits, delay of Site Initiation Visits  brought most of the research to a temporary halt.  Restriction on travel for training caused a delay in proceeding with certain research protocols. Preparing the necessary items that we can, so that we are ready to go when restrictions are lifted, will help to cut down on the overall delay of the protocols.

    Training: Suspension of training activities (staffing levels, social distancing) Training activity was halted, which delayed completion of training.

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  • Rounak Dubey, MD, DNB
    ISCT Telegraft, Junior Associate Editor
    Department of Transfusion Medicine
    All India Institute of Medical Sciences
    Raipur, India

    India has entered into the sixth week of a nationwide lockdown, which came into effect on 25 March 2020, when confirmed COVID-19 patients were around 500. As of April 29, the number of confirmed cases stands at 31,332(including 1007 deaths). For a densely populated nation with more than 1.3 billion people, these numbers allude that the situation has been kept under control so far. One can only hope that easing the lockdown won’t let the genie out of the bottle. As most of the resources have been engaged in combating the pandemic, everything else seems to have taken a backseat for a while.

    It has presented new challenges to the budding field of cellular therapy in India, ranging from maintenance of the supply chain to follow up of the patients. Stempeutics Research Bangalore, a mesenchymal stromal cell company, is presently carrying out three MSC based phase III clinical trials (Critical Limb Ischemia due to atherosclerotic peripheral artery disease, non-healing diabetic foot ulcer and Osteoarthritis Knee) and one Phase IV trial in Critical limb ischemia due to Buerger’s disease using their allogenic, pooled MSC product stempeucel®. The follow up of the patients has become quite difficult as they are not able to visit the clinical trial sites due to the lockdown. They are relying more on telephonic follow up (in some of the cases) to get regular feedback about the well-being of the patients.  This could lead to a lot of protocol deviation and may miss a few important efficacy visits of the enrolled patients. In all the new ongoing trials, the patient recruitment has been stopped, this delaying the timelines for completion of the study. The company is also in the process of getting approval from the regulatory agency for starting a clinical trial using MSCs for the treatment of ARDS due to Pneumonia in COVID-19 patients.

     (Thanks to Dr Pawan Kumar Gupta, MD, DNB, PhD  for sharing the information)

    On another front, the use of convalescent plasma from recovered  COVID-19 patients, has been in the limelight recently. A multicentric, phase II randomized controlled trial to assess the safety and efficacy of convalescent Plasma to limit COVID-19 associated complications has been initiated by the Indian Council of Medical Research(ICMR). The regulatory authorities are also granting accelerated approval for the same. The initial results of this therapy have been encouraging.

    Many Indian firms have also joined the quest for developing a vaccine against the disease, including The Serum Institute of India , which is the world’s largest vaccine manufacturer in terms of number of doses produced. As far as the other drugs(especially chloroquine) are considered, the “Infodemic” had reached here much earlier than the actual pandemic, but any conclusive evidence regarding its efficacy is still awaited. Maybe, it will take more than the lock, stock, and barrel approach for finding the “magic bullet” that everyone is eagerly looking for.

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  • ISCT ANZ Regional Secretary Vicki Antonenas continues her clinical work, processing her last expected shipment of fresh Haematopoietic Progenitor Cells at Sydney International Airport, and prepares to transition to work with frozen Matched Unrelated Donor cells #ISCTTogether

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