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FDA Allows Phase 2b Long COVID Study to Treat Patients Suffering from Long-COVID

SONOMA, Calif. – Pulthera, LLC has received notice from the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) that it can proceed with “A Phase 2b, Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravenous Allogenic Bone Marrow-derived Mesenchymal Stem Cells in Subjects with Dyspnea Associated with Post-acute Sequelae of SARS-CoV-2 Infection.” The study will enroll up to 246 patients into two cohorts, randomized 1:1 to receive the active study drug plus standard treatment or placebo (lactate ringer solution) plus standard treatment, and will use MSCs manufactured by US-based Stemedica Cell Technologies.

Around 23 million people in the U.S. are living with long COVID, which is characterized by symptoms that continue after the initial viral infection for several weeks or more. An estimated 4 million people are unable to work due to the lingering symptoms and effects of long COVID. Because long COVID is such a new phenomenon and it’s not just one condition, it has been very difficult for physicians to effectively treat and manage the post-COVID conditions.

With the help of Rho, Inc., a leading global contract research organization, and protocol chief, Mark Nicolls, MD, who currently serves as Division Chief of Pulmonary, Allergy, and Critical Care Medicine at Stanford University, Pulthera will study the impact of MSCs as a therapeutic to aid those recovering from long COVID.

“Long COVID is a significant health problem that has emerged in the wake of the pandemic. Because long COVID presents in a number of ways that involve symptoms like shortness of breath, brain fog and fatigue, effective therapies are hard to design. MSCs possess broad anti-inflammatory and anti-fibrotic properties that may benefit the underlying condition,” says Nicolls.

The National Institutes of Health (NIH) has received $1 billion from Congress to run the largest research initiative on long COVID in the country, the Researching COVID to Enhance Recovery (RECOVER) initiative. Under the initiative, researchers will study the basic biology underlying long COVID and work on developing possible treatments. Earlier this year, Pulthera submitted a proposal to the NIH to participate in the RECOVER program as it seeks to develop treatments for those suffering from long COVID.

“The pandemic was very disruptive for many months, and we are now having to deal with the long-term impacts of COVID-19. We believe that there are regenerative and anti-inflammatory properties with MSC therapy that will positively impact patients suffering from dyspnea caused by long COVID,” said David Grieve, Founder and Chairman of Pulthera.

With the recent news, Pulthera is working to establish trial sites and clinics across the U.S. where patients can be evaluated and enroll in the clinical trial. Given the broad impact of long COVID, “we expect the study to move quickly and think we will see the positive outcomes MSCs provide to long COVID patients within the next year,” said Grieve.

About Pulthera, LLC

Pulthera, LLC is a US-based biopharmaceutical company focusing on the commercialization of “off the shelf” stem cell therapeutics designed to more effectively treat long COVID and potentially provide a strong defense against future pandemics. The Company has licensed the exclusive right to use, sell and distribute proprietary adult mesenchymal stem cells for all COVID-related and respiratory indications worldwide (some exclusions apply). Visit www.pulthera.com for more information about the Company.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of progenitor cell, protein, and combination therapeutics for underserved medical conditions. Stemedica has developed a proprietary manufacturing technology platform that produces allogeneic progenitor cell products with intellectual property protection under a low-oxygen, low-tension environment in a cGMP-compliant manufacturing facility. The company’s lead drug candidate, ischemia-tolerant mesenchymal stem cells, or itMSCs, is an allogeneic progenitor cell therapy currently in clinical development for the treatment of ischemic stroke, COVID-19 and Alzheimer’s disease. The company’s second drug candidate, ischemia-tolerant neural progenitor cells, or itNSCs, is an allogeneic cell therapy currently in development for spinal cord injury. More information on Stemedica may be found at www.stemedica.com.

ARDS in COVID-19 Patients Phase I Study

ProMedica today announced the promising results of its new study that evaluated the use of stem cells in the treatment of adult COVID-19 patients.

Eight patients elected to participate in a study under Emergency Investigational New Drug (IND) approval by the U.S. Food and Drug Administration (FDA). Patients received either one or two doses of allogeneic bone marrow-derived mesenchymal stem cells manufactured by Stemedica Cell Technologies at its Current Good Manufacturing Practice (cGMP) compliant California State-licensed facility. The first set of patients was treated with one dose of 100 million cells, and the second set received two doses of 50 million cells.

The stem cell treatment resulted in an improved clinical course for the patients. Within 24-48 hours of receiving the stem cells, all patients had a significant reduction in oxygen requirements. Several patients went from an inability to talk or eat due to shortness of breath to speaking in full sentences and eating full meals comfortably shortly after treatment.

The study also found improved inflammatory modulation. In fact, 88 percent of patients had a significant reduction in acute phase reactants, which are markers for reductions in inflammation. The subsequent reduction in inflammatory markers resulted in a reduced ‘cytokine storm’ in 88 percent of patients. Researchers noted that these patients experienced quicker extubation, less lung trauma and less oxygen toxicity.

The stem cell treatment also seemed to accelerate post-discharge recovery. At their one-month follow-up appointments, the patients who received stem cells improved at a faster rate than comparable patients not treated with stem cells. The stem cell treated patients were tolerating more activity, walking farther and not requiring home oxygen when evaluated at 30 days post discharge.

“It has been really exciting for ProMedica to conduct this innovative research, and we are very encouraged by the results. We’re eager to move into the next phase of the study because of the significant potential to help COVID-19 patients, in particular those who continue to experience lung damage after contracting the virus,” said Greg Kasper, vice president medical affairs, metro region, ProMedica. “The residual circulating stem cells end up residing in the lungs as a reservoir, which may lead to improved long-term lung health and a better quality of life post-COVID-19.”

ProMedica is working to secure funding to advance a Phase 2 study in conjunction with Stemedica, a clinical-stage biopharmaceutical company focused on the development and commercialization of progenitor cell and protein therapeutics for underserved medical conditions.

“We know that the immune-modulating properties of stem cells are quite remarkable in that they block the cytokine storm. COVID-19 offers a new frontier for exploring the potential benefits of stem cell therapy and, in particular, a clinical reduction of inflammation. The early findings and clinical outcomes of the study with ProMedica are encouraging, and we are hopeful to move into the next phase soon. Together, we have an opportunity to speed up the discovery of new treatments and potentially minimize the devastation of this pandemic,” said Nikolai Tankovich, president and chief medical officer, Stemedica.

ProMedica is a mission-based, not-for-profit integrated healthcare organization headquartered in Toledo, Ohio. It serves communities in 27 states. The organization offers acute and ambulatory care, an insurance company with a dental plan, and post-acute and academic business lines. The organization has more than 56,000 employees, 13 hospitals, 2,100+ physicians and advanced practice providers with privileges, 900+ healthcare providers employed by ProMedica Physicians, a health plan, and 335 assisted living facilities, skilled nursing and rehabilitation centers, memory care communities, outpatient rehabilitation clinics, and hospice and home health care agencies. Driven by its mission to improve your health and well-being, ProMedica has been nationally recognized for its advocacy programs and efforts to address social determinants of health. For more information about ProMedica, please visit www.promedica.org/aboutus.

Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells used in US-based clinical trials for chronic heart failure, ischemic stroke and Alzheimer’s disease. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stem cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California. For more information, please visit www.stemedica.com.

Phase I Pilot Study | ARDS in COVID-19 Patients Download

FDA Approved Phase II Clinical Trial | ARDS in COVID-19 Patients

Stemedica Cell Technologies, Inc. has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval for “A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients with Moderate to Severe Lung Injury due to COVID-19.” The study will enroll up to 40 patients into two cohorts, randomized 1:1 to receive the active study drug plus standard treatment or placebo (lactate ringer solution) plus standard treatment.

Prior to submission of an IND, fourteen critically ill COVID-19 patients were treated on Emergency Use and Expanded Use INDs at the Providence Saint John’s Health Center, (Santa Monica, CA) and ProMedica (Toledo, OH). The stem cell treatment resulted in an improved clinical course for the patients. Within 24-48 hours of receiving the stem cells, all patients had a significant reduction in oxygen requirements. Several patients went from an inability to talk or eat due to shortness of breath to speaking in full sentences and eating full meals comfortably shortly after treatment.

The study also found improved inflammatory modulation; 88 percent of patients had a significant reduction in acute phase reactants (markers for reductions in inflammation) which resulted in a reduced “cytokine storm.” Researchers noted that these patients experienced quicker extubation, less lung trauma and less oxygen toxicity.

“It was evident from this preliminary experience that ischemic-tolerant mesenchymal stem cells (itMSCs) may play a significant role in treating moderate and severe cases of COVID-19 and require further investigation in a clinical trial to be sponsored by Stemedica,” said Lev Verkh Ph.D. Stemedica’s chief regulatory and clinical development officer.

Several properties of itMSCs make them attractive as a novel biological therapy for severe lung injury due to COVID-19: low immunogenicity; immunomodulatory effects; capacity to suppress excessive pro-inflammatory responses; and ability to secrete epithelial and endothelial growth factors to support the existing alveolar epithelial and endothelial barriers which are often disrupted in acute respiratory distress syndrome (ARDS) leading to respiratory failure from alveolar edema. By targeting multiple aspects of the pathophysiology of ARDS, itMSCs offer a distinct advantage over other pharmacological therapies that may target one component of the syndrome.

“Mesenchymal stem cells that act as a cytokine storm blocker significantly suppress natural killer (NK) cell activation, reducing CXCL1 peptides released by neutrophils resulting in a lesser presence harmful to epithelium and endothelium proteases and oxidants,” said Nikolai Tankovich M.D., Ph.D., Stemedica’s president and chief medical officer. “This results in less damage to the lungs and a better clinical outcome for COVID-19 patients, in particular, for breathing capability.”

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of progenitor cell, protein and combination therapeutics for underserved medical conditions. Stemedica has developed a proprietary manufacturing technology platform that produces allogeneic progenitor cell products with intellectual property protection under a low-oxygen, low-tension environment in a cGMP-compliant manufacturing facility. The company’s lead drug candidate, ischemia-tolerant mesenchymal stem cells, or itMSCs, is an allogeneic progenitor cell therapy currently in clinical development for the treatment of ischemic stroke and Alzheimer’s disease. The company’s second drug candidate, ischemia-tolerant neural progenitor cells, or itNSCs, is an allogeneic cell therapy currently in development for spinal cord injury. More information on Stemedica may be found at www.stemedica.com.