TissueGene
Kolon TissueGene is a Maryland-based biopharmaceutical company dedicated to developing advanced cell therapies for orthopedic diseases and degenerative disorders. Their mission is to provide safe and effective therapies to reduce pain and improve function. They focus on innovative cell and gene therapy technologies, with a pipeline that includes Invossa™, a first-in-class cell and gene therapy targeting osteoarthritis of the knee. The company has a history of clinical trials, regulatory approvals, and strategic partnerships worldwide, aiming to become a leader in regenerative medicine and to develop therapies that can modify disease progression.
Industries
Nr. of Employees
small (1-50)
TissueGene
Rockville, Maryland, United States, North America
Products
Allogeneic cell‑and‑gene therapy for osteoarthritis of the knee (single intra‑articular injection)
A clinical‑stage allogeneic cell‑and‑gene therapeutic approach using primary chondrocytes genetically modified to express a therapeutic growth factor, developed for intra‑articular treatment of knee osteoarthritis with objectives of pain reduction, improved function, and potential disease modification.
Allogeneic cell‑and‑gene therapy for osteoarthritis of the knee (single intra‑articular injection)
A clinical‑stage allogeneic cell‑and‑gene therapeutic approach using primary chondrocytes genetically modified to express a therapeutic growth factor, developed for intra‑articular treatment of knee osteoarthritis with objectives of pain reduction, improved function, and potential disease modification.
Services
Phase II/III Clinical Trial Management
End‑to‑end management of multicenter randomized clinical trials for cell‑and‑gene therapies, including protocol development, site selection, enrollment coordination, data collection, and long‑term follow‑up.
Phase II/III Clinical Trial Management
End‑to‑end management of multicenter randomized clinical trials for cell‑and‑gene therapies, including protocol development, site selection, enrollment coordination, data collection, and long‑term follow‑up.
Expertise Areas
- Clinical trial management (Phase II/III)
- Cell and gene therapy development
- Orthobiologics and musculoskeletal therapeutics
- Regulatory strategy and FDA interactions (SPA, clinical hold management)
Key Technologies
- Allogeneic cell therapy
- Cell‑mediated gene therapy (gene transduction of cells to express therapeutic proteins)
- Intra‑articular delivery
- Magnetic resonance imaging (including contrast‑enhanced MRI)