Clinical Trial


RESTEM has partnered with the University of Florida in this Phase I clinical trial treating patients with dermatomyositis and polymyositis, also known as idiopathic inflammatory myositis (IIM). This FDA-cleared, dose-escalation study has been fully enrolled, with 9 patients treated with the Company’s umbilical cord lining stem cells (ULSCs). The trial is designed to provide durable symptom relief and improve overall health for those living with these debilitating disorders.

Polymyositis is a muscle-associated disease that causes inflammation and weakness of the skeletal muscles responsible for movement. Dermatomyositis is a form of polymyositis that also causes skin rash, in addition to muscle inflammation. Both disorders can significantly compromise quality of life and are very challenging to treat. Currently, the only treatment for these disorders is immunosuppressive drugs, which can be associated with significant toxicity and other side effects. Our objective in this study is to provide a therapy that reduces or eliminates the use of immunosuppressive drugs and improves quality of life.

The phase I trial has commenced and all patients have been recruited. Preliminary results suggest an immunomodulatory effect that is promising for IIM patients, therefore a larger Phase II study is planned that will evaluate this therapy with the overarching goal of bringing this next-generation therapy to routine clinical care.

To learn more about this trial, visit: Phase 1 Study of ULSC in Patients With Polymyositis (PM) and Dermatomyositis (DM) – Full Text View –

To read the Press Release of this trial, visit: UF Center for Regenerative Medicine recruiting for trial on potential therapy for autoimmune disorders | UF Health, University of Florida Health

If you are interested in learning more or getting involved, please contact us