COMPANY

Restem

HQ: Miami, FL source · restem.com ↗ · Southeast

Restem is a clinical-stage biotechnology company with an adult stem cell therapy platform. From company website Source · checked 2026-10-19

Sources for this description (1)

Restem is a clinical-stage biotechnology company with an adult stem cell therapy platform.
- “RESTEM Group is a clinical-stage biotechnology company with a groundbreaking adult stem cell therapy platform with one Phase 2/3I and one Phase 1 clinical trials currently underway, and an additional one Phase 2 trial set to commence.” https://restem.com/about (2026-10-19)

Keywords: immunology autoimmune diseases cell therapy Idiopathic Inflammatory Myositis DERMATOMYOSITIS OR POLYMYOSITIS FSHD - Facioscapulohumeral Muscular Dystrophy Covid19 Corona Virus Infection SARS-CoV Infection ARDS Coronavirus Umbilical Cord Lining Stem Cells

Location: Miami, FL · source · Oct 15, 2026

Profile checked Oct 10, 2026

3Trials (company is sponsor)

Timeline

Jan 6, 2026 Trial start Phase 2/Phase 3: Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM) source ↗
Dec 1, 2025 Trial start Phase 1: Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD) source ↗
Dec 23, 2020 Trial start Phase 1/Phase 2: Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS source ↗

Upcoming milestones

2028-09 (ESTIMATED) · Phase 2/Phase 3 · Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM) · NCT07160205
2028-09 (ESTIMATED) · Phase 1 · Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD) · NCT07086521

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 3

Record	Title	Phase	Status	Start	Primary completion
NCT07160205	Safety and Efficacy of ULSC on Disease Severity and Steroid Tapering in Participants With Dermatomyositis/ Polymyositis (DM/PM), Also Known as Idiopathic Inflammatory Myopathy (IIM)	Phase 2/Phase 3	Recruiting	Jan 6, 2026	2028-09 (estimated)
NCT07086521	Safety and Preliminary Efficacy of ULSC in Facioscapulohumeral Muscular Dystrophy (FSHD)	Phase 1	Recruiting	Dec 1, 2025	2028-09 (estimated)
NCT04494386	Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS	Phase 1/Phase 2	Completed	Dec 23, 2020	May 12, 2023 (actual)