Chronic Post-COVID-19 Syndrome. Stem cells

A randomized, double-blinded, single-center, phase 2 efficacy, and safety study of allogeneic HB-adMSCs for the treatment of patients with Chronic Post-COVID-19 Syndrome
Summary
This is an FDA clinical study to evaluate the safety and efficacy of multiple intravenous administrations of allogenic HB-adMSCs for the treatment of Chronic Post-COVID-19 Syndrome. This study was opened to further understand and provide a possible treatment for this rapidly proliferating and often debilitating condition. Stem cells have become a promising tool for the treatment of autoimmune diseases by promoting tissue repair and protection from immune attack associated damage. The mechanism of action for mesenchymal stem cells have been found to include tissue repair, suppression of activation of T and B lymphocytes, release of anti-inflammatory, release of anti-apoptotic molecules, and changes to the differentiation, maturation, and function of dendritic cells, all of which may aid in correcting immune system imbalance and healing of damaged tissues caused by COVID-19 infection and Post COVID-19 Syndrome. In addition, Hope Biosciences Stem Cell Research Foundation has investigated the autologous HB-adMSC product, cells from the participants themselves, for the treatment of Chronic Post-COVID-19 syndrome in an Intermediate Expanded Access Study. In this study, it was shown that HB-adMSCs are safe and there is a potential of HB-adMSCs improving quality of life for patients. We hope to expand on these findings here by investigating the safety and treatment capability of allogenic or donated HB-adMSCs in Chronic Post-COVID-19 Syndrome.
Description
At every infusion, the participant randomized to treatment will receive one allogenic HB-adMSC infusion of 200 million (2 x 10^8) cells through IV over 1 hour (250ml/hr) by a registered nurse. In addition, procedures to monitor safety and improvement will be conducted including pre-infusion verification of informed consent, cell product quality, medical history updates, current medication updates, adverse event updates, vital signs (Heart Rate, BP, Resp., Temp., SpO2), and a physical exam by a designated physician. During the infusion, vital signs will continue to be monitored and the participant will be observed for a minimum of one hour after the infusion. Fatigue Scale, Visual Analog Scale of Symptoms (VAS), and Short Form 36 Item Health Survey (SF-36) will be completed by the participant at each visit. At Screening, Infusion 1, and End of Study blood tests will be performed to monitor important inflammatory and safety markers (CBC, Platelets, CMP, PT, PTT, TNFa, IL6, and CRP). Two phone calls for follow up will occur at 4 and 8 weeks after the last infusion. The final visit, End of Study, will include the same procedures with the exception of the infusion and monitoring procedures. A written summary of the results of the treatment, including adverse events will be submitted to the FDA after completion of the last follow-up visit.
Outcome Measure
Changes in Visual Analog Scale of Symptoms, Changes in Fatigue Scale, Changes in Quality of life as seen in the SF-36 assessments, and incidents of adverse events.
Outcome Expectation
We hypothesize that the anti-inflammatory properties of mesenchymal stem cells may offer advantages to patients who are participating in this clinical study.
Condition / Disease
Post-COVID-19 Syndrome (“Long Haul” COVID)