Dr. Camilo Ricordi, director of the Diabetes Research Institute (DRI) and Cell Transplant Center at Miami Miller University School of Medicine, and his team of international colleagues report the results of a randomized controlled trial showing umbilical mesenchymal chord-chord. safe gas cell infusion (UC-MSC) reduces the risk of death and speeds up recovery time for the worst COVID-19 patients. Dr. Ricordi ‘s revised paper has just been published in STEM CELLS translation therapy (SCTM) January 2021.
The clinical trial, authorized by the FDA in April last year, was initiated by the Cure Alliance, a 501 (c) (3) nonprofit group of research scientists founded ten years ago by Drs. Ricordi for scientists around the world to share knowledge and accelerate cures of all diseases.
At the onset of the pandemic, they all focus on ending COVID-19-induced tolerance. Dr. Ricordi created a “mini-Manhattan project,” which is the result of the implementation of this important new weapon in the arsenal against COVID-19, especially during this critical period when the new vaccines are circulating. slower than expected and the rate of infection and death tax still complying.
The SCTM paper reports results from 24 patients who were hospitalized at the University of Miami Tower or Jackson Memorial Hospital with COVID-19 who developed major respiratory distress syndrome (SARS), a dangerous and often fatal complication characterized by severe inflammation. and fluid uptake in the lungs. Each patient received two injections of mesenchymal or placebo gas cells, given days apart.
It was a double-blind study. Doctors or patients did not know who received the treatment, who received the placebo. ”
Dr. Camilo Ricordi, Principal Investigator
At one month, 100% of patients (<85) who received the UC-MSC injections survived versus 42% in the control group. The researchers found that the treatment was safe, with no adverse events associated with infusion.
Dr. Ricordi’s team also reports that the recovery time was faster among those in the treatment arm. More than half of the patients treated with the UC-MSC injections returned and returned home from the hospital within two weeks. More than 80% of the treatment group recovered over day 30, compared with less than 37% in the control group.
“It’s like smart bomb technology in the lungs to restore a normal immune response and reverse life-threatening problems,” Dr. Ricordi said.
Only one umbilical cord, delivered from a cesarean section, can produce up to 10,000 doses of COVID-19 treatment.
“Our results confirm the powerful anti-inflammatory, immunomodulatory effect of UC-MSCs. These cells have clearly inhibited the ‘cytokine storm’, a sign of COVID-19 deficiency,” said Giacomo Lanzoni, Ph.D. .D, lead author of the SCTM paper.
“The results are extremely important not only for COVID-19 but also for other diseases characterized by intolerant and hyper-inflammatory immune responses, such as autoimmune Type 1 Diabetes. We look forward to put these cells in clinical trials to stop the progression of type 1 diabetes, “he said. Dr. Lanzoni is Professor of Research, Diabetes Research Institute, Department of Biochemistry and Molecular Biology at Miami Miller University School of Medicine.
Dr. Ricordi’s main team consisted of scientists with experience in gas cells, lung disease and emergency care, but it was the diabetes researchers who started cracking the code. At the DRI, Dr. Ricordi and his colleagues had collaborated with Chinese scientists to study UC-MSCs for the treatment of Type 1 diabetes. When the pandemic began , he learned that these colleagues were now testing the treatment in COVID that was critically ill- 19 patients and reporting success.
Israeli researchers soon joined the researchers, reporting that as many as 100% of patients with treatment survived and recovered faster than those without gas cell treatment. But none of the studies was a randomized trial, the gold standard in science.
The ability to handle them was certainly promising. Mesenchymal cells are known to help with overwhelming immune and inflammatory responses. They also have antimicrobial activity and have been shown to stimulate the regeneration of tension.
In addition, when mesenchymal stem cells are ingested, they migrate naturally to the lungs. just where treatment is needed in COVID-19 patients with life-threatening respiratory distress syndrome,
Dr. Ricordi enrolled Dr. Lanzoni and several key colleagues at Miller School, University of Miami Health System, Jackson Health System, as well as others internationally and across the U.S., including Arnold I .Caplan, Ph.D., of Case Western Reserve. University, the first scientist to recognize mesenchymal cells.
Funding with The Cure Alliance was significantly enhanced by a $ 3 million grant from the North American Construction Trade Unions (NABTU). “The North American Construction Trade Unions have been a strong supporter of the Diabetes Research Institute since 1984, when they began a campaign to fund and build our state-of-the-art research and treatment facility. NABTU has continued to has supported our work over the years, including our mesenchymal gas study which helped guide the way to this clinical trial, “said Dr Ricordi.
Other nonprofits funding the research include Barilla Group and Family, The Fondazione Silvio Tronchetti Provera, Simkins Family Foundation, Diabetes Research Institute Foundation and the National Center for the Advancement of Translational Sciences.
The Cure Alliance continues to raise money and awareness through direct donations and unique initiatives such as SCRUFFY: Our Loyal Pandemic Pooches and the Good, the Bad, and the Crazy Haircuts We Gave Them by Shelley Ross, picture book / art that hit # 1 on the Amazon Best Seller card for the first time and is now on sale worldwide. The 196-page book with warm color illustrations records the life of a dog during its widespread locks as the virus spreads across the planet in just four months. 100% of all profits are directed to COVID-19 research and will continue to help fund the manufacture and distribution of UC-MSC treatment.
A larger clinical trial is ongoing. Until approved by the FDA for widespread use, the UC-MSC treatment will be available to medical centers for compassionate use cases.