Cell therapy weekly: Phase II/III trial of allogeneic MSC therapy for COVID-19-associated ARDS begins enrollment

7 May 2020

Written by RegMedNet

Basic research Clinical trials COVID-19 MSCs News News round-up

This week: researchers utilize ‘nanostimulators’ to boost stem cells’ regenerative capacity in mice and BioLife Solutions (BioLife; DC, USA) announces positive preliminary revenue for the first quarter of 2020.

The news highlights:

Phase II/III trial of allogeneic MSC therapy for COVID-19-associated ARDS begins enrollment
Boosting stem cells’ regenerative capacity with ‘nanostimulators’
Leading bioproduction tool company announces positive preliminary revenue for first quarter of 2020

Phase II/III trial of allogeneic MSC therapy for COVID-19-associated ARDS begins enrollment

Mesoblast (Melbourne, Australia) has announced the start of participant enrollment for its placebo-controlled, Phase II/III clinical trial of Ryoncilâ„¢ (remestemcel-L) — an allogeneic, mesenchymal stem cell (MSC) therapy being investigated for COVID-19-associated, moderate—severe acute respiratory distress syndrome (ARDS). More than 20 medical centers across the USA are to participate in the trial, which will be conducted in collaboration with the Cardiothoracic Surgical Trials Network (MD, USA).

“There are limited treatment options for ventilator-dependent patients with [ARDS], the principal cause of mortality in COVID-19 infection. Based on the encouraging initial results of remestemcel-L treatment under emergency compassionate use in New York, there is an urgent need to execute this robust randomized placebo-controlled trial in order to definitively determine whether this cell therapy can reduce the mortality of patients with COVID-19 ARDS on ventilators,” explained Silviu Itescu (Mesoblast).

Boosting stem cells’ regenerative capacity with ‘nanostimulators’

Researchers from the University of Illinois at Urbana-Champaign (IL, USA) have described their use of ‘nanostimualtors’ — nano-sized particles laced with TNF-Î±, which is naturally produced by the body and can help promote stem cells to perform wound healing — to boost the regenerative capacity of stem cells in a targeted limb with local muscle ischemia in mice. After isolating stem cells from the mice’s fat tissue and incubating them with the nanostimulators, the team injected the cells back into the mice’s affected legs and observed increased blood flow and oxygen levels, as well as mobility improvements in the ischemic legs.

Study co-author Marni Boppart (University of Illinois) explained: “Peripheral artery disease can cause debilitating pain and long-term disability. Unfortunately, there are no consistently effective treatments for this condition. This study is important because it demonstrates the capacity for modified stem cells to effectively treat [peripheral artery disease] in a preclinical model, representing a step closer toward relieving pain in humans.”

Leading bioproduction tool company announces positive preliminary revenue for first quarter of 2020

BioLife Solutions (BioLife; DC, USA), a leading developer and supplier of bioproduction tools for cell and gene therapies, has announced a positive preliminary first quarter revenue for 2020, largely driven by increased demand for biopreservation media. The company saw a 110% year-on-year increase in total revenue for the first quarter of 2020 and a 46% sequential increase over the fourth quarter of 2019.

“As reported by other high-value bioproduction tools suppliers across the advanced therapeutics supply chain, we experienced increased demand during the first quarter as numerous customers placed replenishment and safety stock orders to ensure their clinical development programs could continue unabated during the COVID-19 pandemic,” commented Mike Rice, CEO at BioLife.