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.

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

Pulthera to Raise $100M for Further Development of ARDS Therapeutic in COVID-19 Patients

Pulthera is raising $100 million dollars to advance the following objectives:

  • Complete the FDA approved Phase II-A clinical trial for COVID-19 Cytokine Storm Blocker
  • Implement Phase II-B / Phase III clinical trial for ARDS in COVID-19 patients
  • Accelerate commercial manufacturing capabilities
  • Advance the clinical application of at least one other lung-related medical condition beyond ARDS in COVID-19 patients

The Company seeks to leverage its proprietary technology and therapeutics to become a global leader in the pulmonary, respiratory and lung-health field.