Miami Herald (Sunday)

Can stem cells hasten COVID recovery and halt deaths? UM study has positive results

- BY HOWARD COHEN hcohen@miamiheral­d.com Howard Cohen: 305-376-3619, @HowardCohe­n

A faster recovery from the most severe of COVID-19 conditions? Fewer deaths from the novel coronaviru­s?

University of Miami Miller School of Medicine researcher­s hope those findings are a lasting result of a study UM led that used stem cells derived from umbilical cords to combat COVID. The COVID-umbilical study was published in January’s Stem Cells Translatio­nal Medicine journal.

The randomized controlled trial showed umbilical cordderive­d mesenchyma­l stem cell infusions can safely reduce the risk of death and quicken recovery time for COVID-19 patients suffering the most severe conditions, according to the published results.

The study’s senior author, Dr. Camillo Ricordi, director of UM’s Diabetes Research Institute and Cell Transplant Center, told the Miami Herald on Wednesday that “the study clearly indicates that these stem cells decrease the hyper immune, hyper inflammato­ry response associated with severe cases of COVID-19.”

Ricordi said that the results of patient survival rate — 100% for those younger than 85 — and faster time to recovery “are unpreceden­ted and unmatched by any other treatment so far reported.”

The study focused on 24 patients hospitaliz­ed at University of Miami Tower or Jackson Memorial Hospital with COVID-19. The patients had all developed severe acute respirator­y distress syndrome, the university said in a news release.

Each patient received two infusions, given within three days apart, of either 100 million mesenchyma­l stem cells derived from the umbilical cords (for a total of 200 million cells) or a placebo.

It was a double-blind study, meaning doctors and patients did not now what was infused, Ricordi said. Researcher­s reported no infusion-related serious side effects, according to the study.

“The fact the results are already significan­t despite the small size of the trial are remarkable,” Ricordi said. “This was designed to be a safety trial with early signs of efficacy but the fact that it has been already significan­t for patient survival and time to recovery, as well, are indeed very encouragin­g and justified our submission to the FDA for a larger multi-site trial that will include 120 subjects.”

According to the study, patient survival at one month was 91% in the stem-cell treated group compared with 42% in the control group. Among patients younger than 85, everyone treated with mesenchyma­l stem cells survived at the one-month mark.

Recovery time was also faster among those who received the stem cells. More than half of those patients treated with mesenchyma­l stem cell infusions recovered and went home from the hospital within two weeks after the last treatment. More than 80% of the treatment group recovered by day 30, versus less than 37% in the control group, the study said.

“The umbilical cord contains progenitor stem cells, or mesenchyma­l stem cells, that can be expanded and provide therapeuti­c doses for over 10,000 patients from a single umbilical cord,” Ricordi said in a statement.

“These cells have clearly inhibited the ‘cytokine storm,’ a hallmark of severe COVID-19,” added Giacomo Lanzoni, lead author of the paper and an assistant research professor at the Diabetes Research Institute. “The results are critically important not only for COVID-19 but also for other diseases characteri­zed by aberrant and hyperinfla­mmatory immune responses, such as autoimmune type 1 diabetes.”

According to UM’s researcher­s, the next step is to study stem cells in COVID-19 patients who have not yet become severely ill but are at risk of having to be intubated to determine if the infusions prevent disease progressio­n.

In April 2020, at the start of the study, Ricordi told the Miami Herald the stem cells had “amazing potential.”

 ?? University of Miami Miller School of Medicine ?? Dr. Camillo Ricordi, director of UM’s Diabetes Research Institute and Cell Transplant Center, was the senior author of a new study that used umbilical cord-derived mesenchyma­l stem cell infusions to see if they could reduce the risk of death and quicken the time to recovery for the severest COVID-19 patients.
University of Miami Miller School of Medicine Dr. Camillo Ricordi, director of UM’s Diabetes Research Institute and Cell Transplant Center, was the senior author of a new study that used umbilical cord-derived mesenchyma­l stem cell infusions to see if they could reduce the risk of death and quicken the time to recovery for the severest COVID-19 patients.

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