Therapeutic Solutions International is targeting long COVID with a new stem cell therapy, as Tonix and Pfizer explore their own treatment options.
As the COVID-19 pandemic continues, Therapeutic Solutions International is jumping into the COVID-19 treatment space. The company is not making vaccines or antivirals—instead, it is targeting long COVID lung damage with a new stem cell therapy.
Therapeutic Solutions just launched a randomized, double-blind, placebo-controlled Phase III study of its new treatment, JadiCell. In centers across multiple countries, 128 patients struggling with COVID-19-associated lung failure will receive either JadiCell treatment or a placebo. After 60 days, the participants will be evaluated according to respiratory failure rates.
JadiCell is a treatment that consists of live mesenchymal stem cells, a family of unique adult stem cells that help produce higher-level therapeutic factors than other types of stem cells. Therapeutic Solutions has performed previous studies that showed that JadiCell cell therapy works more effectively than other types of stem cells from bone marrow, adipose tissue and umbilical cord blood.
“Cell therapy is one of the most promising and demanding forms of medical intervention,” Chris O’Brien, CEO of Biorasi, the company in charge of running the clinical trial for Therapeutic Solutions, said in a statement. “In contrast to traditional medicines, products such as JadiCell are living therapeutics, which require a very detail-oriented approach to their administration as well as patient follow-up.”
JadiCell’s healing properties could help the damaged lungs of people suffering from long COVID. Long COVID, sometimes referred to as post-acute sequelae of SARS-CoV-2, occurs when the virus has been cleared from the body, but COVID symptoms persist. People are diagnosed with long COVID if they’ve had symptoms that last for longer than four weeks.
Usually, the symptoms of long COVID are caused by the body’s own immune system response to the virus, which causes residual damage to various organs in the body. In addition to the damage from the virus, long COVID is concerning because the patients can incubate new variants of the disease.
“The launch of this clinical trial is a historical step for Therapeutic Solutions International, but also to patients with degenerative lung diseases in general,” Dr. James Veltmeyer, principal investigator of the clinical trial and chief medical officer of Therapeutic Solutions International said.
Other companies are also working hard on treatments for long COVID. In April 2022, Tonix Pharmaceuticals received investigational new drug (IND) clearance from the U.S. Food and Drug Administration to assess TNX-102 SL in a Phase II clinical trial in long COVID patients.
TNX-102 SL is a sublingual tablet made from cyclobenzaprine hydrochloride. It was already undergoing clinical development for fibromyalgia, PTSD, alcohol use disorder and agitation in Alzheimer’s disease when Tonix decided to test it on long COVID too.
“We are excited to have received the FDA’s IND clearance to begin clinical trials of TNX-102 SL for the treatment of Long COVID,” Seth Lederman, M.D., CEO at Tonix, said at the time. “Our experience with TNX-102 SL in fibromyalgia is the motivation for undertaking the development of TNX-102 SL in patients with Long COVID whose symptoms overlap with fibromyalgia.”
Pfizer may also have a solution for long COVID. The pharma giant’s Paxlovid was the first oral antiviral approved by the FDA. It received an Emergency Use Authorization in December 2021 to treat patients 12 years and older with COVID, but now some are wondering if the drug is useful for long COVID too.
Currently, the evidence for Paxlovid’s benefit in treating long-term symptoms is largely anecdotal. Pfizer has no clinical trials testing it for this purpose. Even so, Reuters noted a case in which a physician prescribed Paxlovid to a patient with long COVID symptoms. After three days of taking the antiviral, her health returned to normal.
A second case occurred when immunologist Lavanya Visvabharathy, who works at Northwestern medicine’s long COVID clinic, got sick. She was infected with COVID in December 2021. After four months of chronic symptoms, she prescribed herself Paxlovid and saw improvements days after.
Of all these companies, though, Therapeutic Solutions seems to have one of the most promising treatments with JadiCell.
“Given its unparalleled ability to stimulate angiogenesis, suppress lung inflammation, augment healing of scar tissue in the lung, and stimulate endogenous lung stem cells, I have high confidence in the rapid success of our clinical trial [of JadiCell],” said Thomas Ichim, who is on the board of directors at Therapeutic Solutions.
