Safety Evaluation of Intracoronary infusion of extracellular vesicles in patients with AMI (EV‐AMI)

This research tests a new product for patients who have had a heart attack (AMI, acute myeocardial infarction). This product would help protect and regenerate cells in a heart damaged by AMI.

Rion is a clinical‐phase regenerative medicine company based in Rochester, MN, focused on bringing novel regenerative technologies solving unmet medical needs of the people of Minnesota.

Rion LLC
Atta Behfar, MD, PhD

CELLTOP: A Phase I Clinical Trial of Autologous Adipose Derived Mesenchymal Stem Cells in the Treatment of Paralysis due to Traumatic Spinal Cord Injury

This clinical trial investigates whether adipose-derived (fat tissue-derived) mesenchymal stem cells can be safely administered into the cerebrospinal fluid of patients with traumatic spinal cord injury and what the effects this may have on functional improvement, activities of daily living, and quality of life. If successful, this study may create a viable clinical option for spinal cord injury patients by establishing feasibility and safety data for patients who do not have many treatment options.

Mayo Clinic
Mohamad Bydon, MD

Fetoscopic regenerative therapy for severe pulmonary hypoplasia - a feasibility pre-randomized controlled trial study

When a baby’s lungs are not adequately developed at birth, severe complications and even death can result. Dr. Ruano brings expertise in a technique that uses a minimally invasive procedure to intervene while the fetus is still in the uterus. He will participate as one investigator in a larger clinical trial to see if this procedure can regenerate the process of lung growth and development before birth.

Year One Progress Report:

Mayo Clinic
Rodrigo Ruano, MD, PhD

Phase I/II study of human chorionic gonadotropin and epidermal growth factor supplementation (Pregnyl) to support tolerance and repair as adjunct therapy in high-risk or refractory acute graft-versus-host disease

Interim report: Patient enrollment continues. Additionally, correlative studies have provided important data on regulatory T cell responses and other markers that give insight to the clinical trial and help strengthen the results.

This grant is in no-cost extension through 2/28/2020.

University of Minnesota
Shernan G. Holtan, MD

A Phase IIA study using intrathecal treatment of autologous adipose-derived mesenchymal stem cells for amyotrophic lateral sclerosis

The overall objective of this proposal is to conduct a multi-site, placebo-controlled Phase IIA clinical trial to obtain clinical data on the safety, efficacy and mechanism of action of intrathecal injection of adipose-derived mesenchymal stem cells as a regenerative therapy for the treatment of the incurable condition, amyotrophic lateral sclerosis.

Read Staff’s most recent interim report here

Mayo Clinic
Nathan P. Staff, MD, PhD

Phase I study of delivery of autologous bone marrow derived mononuclear cells to myopathic right ventricle in patients with Ebstein anomaly during surgical intervention

The goal of this Phase I study is to establish the safety and feasibility of intramyocardial injection of autologous bone marrow derived mononuclear cells (BM-MNC) into the myopathic right ventricle of patients with Ebstein anomaly (EA) at time of elective cardiac surgery.

In no-cost extension to enroll additional patients in study

Read Holst’s most recent NCE Interim Progress Report here

Mayo Clinic
Kimberly Holst, MD