The FDA is in dire need of reform.
by: Rob Low
Mar 28, 2020 https://kdvr.com/news/coronavirus/could-stem-cells-treat-covid-19/020
DENVER (KDVR) -- A small study in China has some Colorado doctors promoting the use of umbilical stem cells to treat COVID-19 patients.
“Seven patients got the umbilical cord stem cells, three got placebos. All seven of the patients who were treated - and these are severe and critically severe patients - every last one of them got off the ventilator and walked out of the hospital,” said Dr. Scott Faulkner, an internal medicine doctor at Grand River Hospital in Rifle, Colorado.
While the sample size was tiny, Faulkner, who owns Stem Cell Centers of Colorado in Castle Rock, said the results were too promising to ignore.
"We have a plethora of them in tissue banks from coast to coast we could be treating thousands of patients right now,” said Faulkner.
One of those blood banks is Cord for Life in Orlando, Florida, owned by Syed Raheel.
“If we can save one life, it’s as if we saved the entire nation,” said Raheel.
He’s agreed to donate $600,000 worth of stem cells, which is enough to treat 100-150 COVID-19 patients.
“The government has its rules and regulations. We all have to work in those guidelines. But unfortunately, COVID-19 is beating us right now,” said Raheel.
Both Raheel and Faulkner want the FDA to cut through the red tape and approve the use of umbilical stem cells immediately as a compassionate use treatment for the sickest COVID-19 patients.
Instead, they say the FDA has told them to conduct a clinical study first.
“We do not have the time to do extensive studies. We don't have the luxury of doing controlled trials especially at this point,” said Dr. Rajen Naidoo, an orthopedic surgeon in West Palm Beach, Florida.
He’s studied stem cells for years and recently used telemedicine to treat two patients in the Philippines.
He said a 76-year-old woman with severe complications died soon after getting the treatment but a 56-year-old woman showed dramatic improvement within 12 hours.
“She was taken out of the ICU today…it feels promising,” said Naidoo.
He believes stem cells can help patients get off ventilators faster and even allow some patients to avoid needing ventilators in the first place.
“We would probably be surprised by the number of patients that we can help with this,” said Naidoo.
Dr. Jack Zamora is a cosmetic doctor in Denver and another proponent of stem cell therapy.
Zamora is on the board of Vitro Bio Pharma, a stem cell lab in Golden.
He is submitting an application to the FDA next week for the emergency use of stem cell treatment, which he insists are known to have no side effects.
Zamora said at this point, the U.S. has nothing to lose but time.
“Once you have reached the level of severe sickness and illness where every other measure has been exhausted, really what’s the loss here?” he said.
Colorado Congressman Scott Tipton (R) told FOX31 he has personally called the FDA about fast-tracking the use of stem cell treatment, but hasn’t received a response.
By email, the FDA told Investigative Reporter Rob Low it couldn’t discuss stem cell treatments specifically but referred the Problem Solvers to a March 19 press release that said in part:
“Quickly after the emergence of this virus, the FDA began working directly with partners and innovators to foster the development of medical countermeasures against COVID-19, and we are continuing to provide regulatory flexibility, advice, guidance, and technical assistance. The FDA continues to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate. The FDA is able to, and has been, turning around requests very quickly to assist in initiating clinical trials.
For example, last month, the National Institutes of Health (NIH) began a randomized controlled trial for the treatment of COVID-19 patients with the investigational antiviral drug remdesivir."
Zamora told FOX31 that if he gets approval, he’s already heard from hard-hit hospitals in New Orleans that want to work with him to use stem cell therapy on some of its COVID-19 patients.
by: Rob Low
Mar 28, 2020 https://kdvr.com/news/coronavirus/could-stem-cells-treat-covid-19/020
DENVER (KDVR) -- A small study in China has some Colorado doctors promoting the use of umbilical stem cells to treat COVID-19 patients.
“Seven patients got the umbilical cord stem cells, three got placebos. All seven of the patients who were treated - and these are severe and critically severe patients - every last one of them got off the ventilator and walked out of the hospital,” said Dr. Scott Faulkner, an internal medicine doctor at Grand River Hospital in Rifle, Colorado.
While the sample size was tiny, Faulkner, who owns Stem Cell Centers of Colorado in Castle Rock, said the results were too promising to ignore.
"We have a plethora of them in tissue banks from coast to coast we could be treating thousands of patients right now,” said Faulkner.
One of those blood banks is Cord for Life in Orlando, Florida, owned by Syed Raheel.
“If we can save one life, it’s as if we saved the entire nation,” said Raheel.
He’s agreed to donate $600,000 worth of stem cells, which is enough to treat 100-150 COVID-19 patients.
“The government has its rules and regulations. We all have to work in those guidelines. But unfortunately, COVID-19 is beating us right now,” said Raheel.
Both Raheel and Faulkner want the FDA to cut through the red tape and approve the use of umbilical stem cells immediately as a compassionate use treatment for the sickest COVID-19 patients.
Instead, they say the FDA has told them to conduct a clinical study first.
“We do not have the time to do extensive studies. We don't have the luxury of doing controlled trials especially at this point,” said Dr. Rajen Naidoo, an orthopedic surgeon in West Palm Beach, Florida.
He’s studied stem cells for years and recently used telemedicine to treat two patients in the Philippines.
He said a 76-year-old woman with severe complications died soon after getting the treatment but a 56-year-old woman showed dramatic improvement within 12 hours.
“She was taken out of the ICU today…it feels promising,” said Naidoo.
He believes stem cells can help patients get off ventilators faster and even allow some patients to avoid needing ventilators in the first place.
“We would probably be surprised by the number of patients that we can help with this,” said Naidoo.
Dr. Jack Zamora is a cosmetic doctor in Denver and another proponent of stem cell therapy.
Zamora is on the board of Vitro Bio Pharma, a stem cell lab in Golden.
He is submitting an application to the FDA next week for the emergency use of stem cell treatment, which he insists are known to have no side effects.
Zamora said at this point, the U.S. has nothing to lose but time.
“Once you have reached the level of severe sickness and illness where every other measure has been exhausted, really what’s the loss here?” he said.
Colorado Congressman Scott Tipton (R) told FOX31 he has personally called the FDA about fast-tracking the use of stem cell treatment, but hasn’t received a response.
By email, the FDA told Investigative Reporter Rob Low it couldn’t discuss stem cell treatments specifically but referred the Problem Solvers to a March 19 press release that said in part:
“Quickly after the emergence of this virus, the FDA began working directly with partners and innovators to foster the development of medical countermeasures against COVID-19, and we are continuing to provide regulatory flexibility, advice, guidance, and technical assistance. The FDA continues to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate. The FDA is able to, and has been, turning around requests very quickly to assist in initiating clinical trials.
For example, last month, the National Institutes of Health (NIH) began a randomized controlled trial for the treatment of COVID-19 patients with the investigational antiviral drug remdesivir."
Zamora told FOX31 that if he gets approval, he’s already heard from hard-hit hospitals in New Orleans that want to work with him to use stem cell therapy on some of its COVID-19 patients.