Compassionate Use for Clinical Trials with Stem Cells - COVID-19 Clinical Trial
Breaking News | COVID-19

Compassionate Use for Clinical Trials with Stem Cells

Global Institute of Stem Cell Therapy and Research (GIOSTAR), the worldwide leader in stem cell research, is pleased to announce that they have received an approval for a COVID-19 clinical trial, led by their Medical Director Dr. Prabhat Soni. GIOSTAR will conduct the trial using stem cells to treat COVID-19 patients, under the approval of the United States Food and Drug Administration (FDA) “expanded access for compassionate use” program. The Institute is exploring a promising alternative approach to the devastating disorder, which leverages the anti-inflammatory properties of mesenchymal stem cells (MSCs). According to Dr. Soni, the investigation is based upon two decades of stem cell research by GIOSTAR Co-Founder, Chairman and Chief Scientific Officer Dr. Anand Srivastava.

  • prnewswire.com/news-releases/giostar-announces-fda-approval-under-compassionate-use-for-a-covid-19-clinical-trial-with-stem-cells-301051830.html

Nassau County Reaching Benchmarks Toward Reopening

Nassau County is meeting some key federal benchmarks to start reopening business activity following the coronavirus shutdown, while Suffolk County is not far behind, officials said Wednesday.

Cuomo unveiled a 12-point regional template that must be met for certain businesses to resume after May 15.

  1. Meet federal Centers for Disease Control and Prevention guidelines of seeing a 14-day decline in hospitalizations rates.
  2. Identify industries that will bring people back to work and get the economy going while abiding by social distancing. Phase one includes construction and manufacturing. Must identify businesses for the second phase.
  3. What business or precautions are in place? Have businesses come up with plans and precautions to maintain a safe work environment, such as implementing social distancing policies, monitoring and taking workers’ temperatures. Also have to ensure they’re not creating an “attractive nuisance,” meaning they’re opening a facility or attraction that could draw people to the area from elsewhere.
  4. Monitor health care capacity and ensure it remains below 70 percent, including with ICU beds. Hospitals should also prepare for an influx of patients in the fall from flu season and stockpile personal protective equipment such as masks and gowns.
  5. Implement a testing regimen of 30 tests for every 1,000 people, as well as advertising, sites and turnaround time for results.
  6. Implement a tracing system in place in coordination with Mayor Michael Bloomberg. Regions should have at least 30 tracers per 100,000 people.
  7. Have two-week isolation facilities in place for people who get sick and don’t want to quarantine at home.
  8. Coordinate regionally on what to do with schools, transportation, testing and tracing.
  9. Reimagine telemedicine.
  10. Reimagine tele-education
  11. Install a regional control room that can monitor infections and hospital capacity and hit an emergency off switch if the region enters a danger zone.
  12. Protect and respect essential workers with adequate access to testing and equipment, as well as disinfecting public transit.

Gov. Andrew M. Cuomo, who will make the ultimate decision on reopening plans, has not eased restrictions yet for Long Island or other downstate areas — though on Wednesday he did say hospitals in 35 upstate counties could resume elective surgeries postponed because of the pandemic.


Novartis to Test Canakinumab for COVID-19, as IL-6 trial Disappoints

Novartis intends to recruit around 450 patients into the study at sites in France, Germany, Italy, Spain, UK and the US, who will be treated with either canakinumab or placebo on top of standard care for COVID-19.

The primary objective of the study is to demonstrate the benefit of canakinumab in increasing the chance of survival without the need for invasive mechanical ventilation, says Novartis, which thinks it could have results available in the late summer.

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