Restem, LLC.
Clinical-stage biotechnology company developing cell-based therapeutics that modulate immune responses and target cellular senescence. Core programs include an umbilical cord lining-derived progenitor cell therapy and an activated natural killer (aNK) cell therapy. The company reports completed Phase 1 studies, ongoing Phase 1 and Phase 2 trials, and is preparing Phase 2/3 registrational trials. Operations describe end-to-end clinical and commercial-scale manufacturing, regulatory interactions with the FDA, and publication and conference activity.
Industries
Nr. of Employees
small (1-50)
Restem, LLC.
Corporate Office: 1728 Coral Way Suite 500, Miami, FL 33145; Labs: 355 E Rincon St. Suite 125, Corona, CA 92879
Products
Umbilical cord lining-derived progenitor cell therapy (ULSC program)
Allogeneic, off-the-shelf progenitor cell therapy derived from umbilical cord lining intended to modulate immune responses in autoimmune diseases.
Activated NK cell therapy (aNK program)
Ex vivo propagated and activated NK cell product aimed at clearing senescent cells and reducing immunosenescence for aging-related indications.
Secretome/exosome-derived topical products
Topical formulations derived from cell-secreted secretome and exosomes intended for skin and hair applications; produced from culture-expanded progenitor cells and purified by filtration.
Umbilical cord lining-derived progenitor cell therapy (ULSC program)
Allogeneic, off-the-shelf progenitor cell therapy derived from umbilical cord lining intended to modulate immune responses in autoimmune diseases.
Activated NK cell therapy (aNK program)
Ex vivo propagated and activated NK cell product aimed at clearing senescent cells and reducing immunosenescence for aging-related indications.
Secretome/exosome-derived topical products
Topical formulations derived from cell-secreted secretome and exosomes intended for skin and hair applications; produced from culture-expanded progenitor cells and purified by filtration.
Services
Design and conduct of clinical studies (Phase 1–3), safety and efficacy assessment, and regulatory interactions to support product approval.
Commercial-scale, GMP-aligned production of allogeneic cell therapies and clinical-grade NK cell products.
Design and conduct of clinical studies (Phase 1–3), safety and efficacy assessment, and regulatory interactions to support product approval.
Commercial-scale, GMP-aligned production of allogeneic cell therapies and clinical-grade NK cell products.
Expertise Areas
- Cell therapy development
- Allogeneic manufacturing (off-the-shelf cell products)
- Ex vivo NK cell activation and expansion
- Exosome/secretome-based therapeutics
Key Technologies
- Umbilical cord lining-derived progenitor cells
- Allogeneic cell therapy manufacturing (GMP-compliant)
- Ex vivo NK cell expansion and activation
- Exosome/secretome isolation and multi-stage filtration
News & Updates
Company-hosted R&D day to present its immunomodulatory treatment pipeline for autoimmune and inflammatory diseases.
Presentation of the Phase 2/3 IIMPACT trial design for idiopathic inflammatory myopathy.
Corporate presentation and investor materials describing pipeline and strategy.
Regulatory Fast Track designation granted by the FDA for the company’s umbilical cord lining-derived cell therapy program in idiopathic inflammatory myopathy.
Orphan Drug designation granted by the FDA for the umbilical cord lining-derived cell therapy program for polymyositis and dermatomyositis.
Presentation of Phase 1 clinical data showing safety and clinical improvements in polymyositis/dermatomyositis.
Company-hosted R&D day to present its immunomodulatory treatment pipeline for autoimmune and inflammatory diseases.
Presentation of the Phase 2/3 IIMPACT trial design for idiopathic inflammatory myopathy.
Corporate presentation and investor materials describing pipeline and strategy.
Regulatory Fast Track designation granted by the FDA for the company’s umbilical cord lining-derived cell therapy program in idiopathic inflammatory myopathy.
Orphan Drug designation granted by the FDA for the umbilical cord lining-derived cell therapy program for polymyositis and dermatomyositis.
Presentation of Phase 1 clinical data showing safety and clinical improvements in polymyositis/dermatomyositis.