NEPHSTROM consortium assembles for plenary meeting

The NEPHSTROM project held an online plenary meeting on Friday, 9 March 2021. Representatives from each of the project partners gathered to discuss the recently granted six-month no-cost extension and to plan for the remainder of the project.

The meeting provided an opportunity to mark the inclusion of the final patient at the Bergamo trial site. Participants are still being enrolled in the trial sites at Galway and Birmingham. The Clinical Research Facility in Galway reports that enrolment for the mid-dose cohort receiving 160 million cells has commenced at Galway University Hospital with 2 people enrolled so far. For specifics of the NEPHSTROM clinical trial, see https://nephstrom.eu/the-project/the-clinical-trial/.

The NEPHSTROM partners look forward to bringing the trial and the project to a successful conclusion.

NEPHSTROM Galway trial team adapts to new patient safety needs

Dr. Sarah Cormican, Dr. Veronica McInerney, Prof. Matthew Griffin and Mr. Nathan Devaney

The NEPHSTROM Galway trial team has developed a new trial visit workflow to meet the public health guidelines for COVID-19 protection for patients. They were able to successfully complete the end-of-study visit protocol for one of the NEPHSTROM patients and will complete further trial visits in a similar manner in July.

Prof Matthew Griffin, of NUI Galway and Galway University Hospitals, “To date, one end-of-study trial visit has been safely completed. This was only possible because of the expertise and ingenuity of Dr Veronica McInerney who developed the COVID-19 risk assessment and secured a safe location for us to run the protocol with minimal risk to all involved, and of Nathan Devaney and Sarah Cormican who spent the day along with Veronica working carefully with our patient and samples”.

 

Regenerative Medicine Network publishes EU-MSC2 meeting report featuring NEPHSTROM

NEPHSTROM results were presented at EU-MSC2,  a bi-annual event, organized by partners Leiden University Medical Center in The Netherlands. The meeting assembles researchers, clinicians and cell product developers working within EU-sponsored research consortia, that focus on mesenchymal stromal cell (MSC) therapy for immune-related disorders and tissue regeneration. EU-MSC2, a much-anticipated event provides excellent opportunities for networking, […]

NEPHSTROM Clinical Trial Underway at Four Locations

“We are pleased the NEPHSTROM clinical trial has commenced and that randomized diabetic patients with kidney disease whose previous therapies failed now are receiving ORBCEL-M™ immunotherapy,” said Dr Larry Couture, CEO of Orbsen Therapeutics. “The study may be a breakthrough moment for patients with end-stage renal disease caused by diabetes.”

Orbsen Therapeutics, a biotechnology company focused on the discovery, development and commercialization of first-in-class stromal cell immunotherapies, announced that ORBCEL-M™, a second generation stromal cell immunotherapy, currently is being administered to patients with type 2 diabetes and progressive diabetic kidney disease in a four-site, pan-European Phase I/II clinical trial.

Orbsen’s patented allogeneic ORBCEL-M yields nearly 100 percent pure stromal cells, a significant increase in purity when compared to first generation stromal cell therapies. The NEPHSTROM study aims to prove whether the purer stromal cells in ORBCEL-M will be more effective in the prevention and treatment of diabetic kidney disease. Up to 40 percent of people with diabetes will develop kidney disease. Many will require a kidney transplant or a lifetime of dialysis.

“It’s a privilege to have the first patients enrolled and receiving treatment at the Mario Negri Institute,” said Professor Giuseppe Remuzzi of the Mario Negri Institute in Bergamo, Italy, and the clinical trial’s lead investigator. “The complementary skills and expertise of the four participating European centers provide a critical network demonstrating the clinical feasibility of this innovative therapy and the opportunity for additional coordinated trials in diabetic patients with progressive kidney disease for whom new therapies are urgently needed.”

Professor Timothy O’Brien, founding Director at Orbsen Therapeutics and coordinator of the NEPHSTROM study noted, “In my clinical practice, I see hundreds of patients with diabetic kidney disease who face the unpleasant possibility of dialysis or kidney transplantation. The outcome of this clinical trial may give patients another alternative and new hope.”

ORBCEL-M performed well in pre-clinical models as a therapy for diabetic kidney disease demonstrating significant improvements in kidney function.

“Encouraged by the promising results of the pre-clinical models, we are optimistic taking ORBCEL-M to the next stage to further investigate the immunotherapy as a solution to slow or stop progressive diabetic kidney disease,” said Steve Elliman, Chief Scientific Officer at Orbsen Therapeutics. “On behalf of Orbsen, we are privileged to be engaged with some of the European Union’s leading researchers and institutions through NEPHSTROM.”

NEPHSTROM’s four primary research locations are:

Read the press release here.

Read an interview with NEPHSTROM Coordinator Prof Tim O’Brien, NUI Galway and PI Dr Eric Austin of the NHSBT conducted by the Regenerative Medicine Network.