Patient Safety as First Priority in COVID-19 Treatment

The medical and scientific communities are ardently working on promising new treatments for COVID-19. With the urgency to treat patients currently affected by COVID-19, it is perhaps even more critical that patient safety remains the top priority of health officials and therapeutic product developers. Administering novel treatments, including MSC-based treatments, within established medical and regulatory frameworks is an important part of ensuring patient safety. This includes ensuring the quality of critical raw materials with appropriate viral and safety testing, control over the manufacturing process of the product, and oversight by appropriate regulatory agencies. To this end, the International Society for Cell & Gene Therapy issued a statement emphasizing the necessity of working within proper clinical pathways and highlighting how unproven interventions hamper the field.[1]

Accelerated Clinical Pathways

Fortunately, moving through these proper pathways has been accelerated, as the FDA along with other governmental agencies have prioritized the review of COVID-19 therapies. In fact, the FDA has announced the Coronavirus Treatment Acceleration Program (CTAP), which prioritizes bringing “new therapies to sick patients as quickly as possible while at the same time supporting research to evaluate whether these medical countermeasures are safe and effective for treating patients” (FDA Press Release CTAP).[2] In addition to the many resources published by the FDA, the Alliance for Regenerative Medicine recently hosted a webinar [3] where FDA officials discussed the effect of COVID-19 on ongoing clinical trials and the CTAP initiative, with officials stating that most study protocols for treatment of COVID-19 had been reviewed within 24 hours of submission.

Novel, experimental treatments have already been made available to patients using this accelerated path. As of March 31 (the latest available data from the FDA), ten therapeutic agents were in active trials with another fifteen in planning stages (FDA Website CTAP).[4] Cell-based therapeutics feature prominently on this list with Celularity (Celularity Press Release), [5] Mesoblast (Mesoblast Press Release),[6] and the University of Miami Miller School of Medicine (Euro Pharm Review),[7] announcing their INDs for treatment of COVID-19 patients.  According to CellTrials.org [8], the broader tally of new, cell and/or gene therapy related trials for COVID-19 is up to 41.[9]  A clinical trial demonstrating safe and effective treatment would ultimately result in a much-needed COVID-19 treatment, as well as offer evidence to support investigation into a cell-based treatment option for ARDs, and possibly other similar respiratory diseases (see our recent blog posts on this topic).[10] [11] [12]

Hope for COVID-19 Treatment

These unified and concerted efforts by the medical field, therapeutic product developers, and regulatory agencies to find an effective treatment, while maintaining patient safety as the first priority, offer hope that an effective and safe treatment is on the horizon.

Find out how RoosterBio can help you scale your hMSC manufacturing needs in Response to COVID-19.

References

1. ISCT. ISCT takes a stand against organizations marketing unproven COVID-19 cell and gene therapies. ISCT 2020; Available from: https://isctglobal.org/news/497106/ISCT-takes-a-stand-against-organizations-marketing-unproven-COVID-19-cell-and-gene-therapies.htm.
2. Query to Clinicaltrials.gov: COVID mesenchymal, interventional. clinicaltrials.gov 2020; Available from: https://clinicaltrials.gov/ct2/results?cond=COVID&term=mesenchymal&cntry=&state=&city=&dist=&Search=Search&type=Intr.
3. Purohit-Sheth, T, Irony, Ilan. FDA Clinical Trial Guidance During COVID-19. alliancerm.org 2020; Available from: https://alliancerm.org/arm-event/cell-gene-webinar-series#FDAclinicaltrials.
4. Coronavirus Treatment Acceleration Program (CTAP). FDA.gov 2020; Available from: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap.
5. Cellularity. Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy. prnewswire.com 2020; Available from: https://www.prnewswire.com/news-releases/celularity-announces-fda-clearance-of-ind-application-for-cynk-001-in-coronavirus-first-in-cellular-therapy-301034141.html.
6. Mesoblast. FDA Clears Investigational New Drug Application for Mesoblast to Use Remestemcel-L in Patients with Acute Respiratory Distress Syndrome Caused by COVID-19. investorsmedia.mesoblast.com 2020; Available from: http://investorsmedia.mesoblast.com/static-files/f9eb8ecd-9c72-4207-8a51-0187607948b6.
7. Chan, JF, et al., Improved molecular diagnosis of COVID-19 by the novel, highly sensitive and specific COVID-19-RdRp/Hel real-time reverse transcription-polymerase chain reaction assay validated in vitro and with clinical specimens. J Clin Microbiol, 2020. 10.1128/JCM.00310-20
8. Cell Trials Data. CellTrials.org 2020; Available from: https://celltrials.org/about.
9. CellTrials.org COVID-19 Clinical Trials. CellTrials.org 2020; Available from: https://celltrials.org/public-cells-data/celltrials.org-covid-19-clinical-trials/79.
10. RoosterBio. RoosterBio Blog Page #COVID-19. 2020; Available from: https://www.roosterbio.com/category/covid-19/.
11. Carson, J. Patience for hMSCs in COVID-19: We Must Crawl Before We Run. RoosterBio Blog 2020; Available from: https://www.roosterbio.com/covid-19/patience-for-hmscs-in-covid-19-we-must-crawl-before-we-run/.
12. Lim, M. The Race to Beat COVID-19 with hMSCs Revs Up. RoosterBio Blog 2020; Available from: https://www.roosterbio.com/covid-19/the-race-to-beat-covid-19-with-hmscs-revs-up/.