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CC-101 — The Science
A patented, off-the-shelf neural stem cell therapy
CC-101
CC-101 is an allogeneic neural stem cell product candidate licensed from Stanford University, where it was created and originally called NR1 (Neuro Regeneration 1). Delivered as a single, intracerebral dose, CC-101 acts as a “clarion call” — awakening the brain’s own repair mechanisms and driving the formation of new neural connections after chronic ischemic stroke.
This clarion call, also known as a paracrine effect, is mediated by groups of proteins made by CC-101 that can trigger:
- Immune modulation
- Neurogenesis
- Rewiring (plasticity)
- Extracellular matrix remodeling
- Angiogenesis
CC-101 cells do not last forever, but their effect is long-term.
“A single dose of CC-101, delivered to living brain adjacent to the stroke damage, triggers the brain's own repair pathways into action.”
Dr. Gary K. Steinberg — Clarion Cells' Scientific Founder
Mechanism of Action
CC-101 does not replace damaged neurons directly. It signals the brain's native neural stem cells to activate and differentiate, reconstituting the cellular machinery required for repair.
1
A one-day procedure
CC-101 is administered in one day as a single intracerebral dose, placed adjacent to the stroke-damaged area under stereotactic guidance through a single dime-sized skull access point. The procedure is designed to allow the patient to return home the same day. To date, treatment has been given any time from six months to five years after an acute stroke. In Phase 2b, this window has been extended out to seven years.
2
Trophic signaling
Once in place, the cells secrete trophic factors — a biological signal that reaches the dormant endogenous neural stem cells abutting the stroke lesion. Rather than replacing damaged tissue directly, CC-101 acts as fertilizer for the brain's own repair pathways.
3
Endogenous differentiation
Activated native neural stem cells can differentiate into the three essential cell types for brain repair — neurons, oligodendrocytes, and astrocytes — reconstituting the machinery needed to rebuild lost circuits.
4
Functional recovery
As new neural connections form, motor pathways are restored, enabling measurable recovery of motor function that was lost at the time of the original stroke.
Manufacturing
Manufacturing
CC-101 is manufactured to be off-the-shelf — pre-produced, cryopreserved, and ready for use. No patient-specific processing is required, which enables scalable delivery and avoids the delays of autologous cell therapies.
Allogeneic
Derived from a single donor source, enabling standardized production and consistent quality across every dose.
Off-the-shelf
Pre-manufactured and cryopreserved — no patient-specific processing, no waiting period between diagnosis and treatment.
Scalable
Manufacturing process designed for commercial-scale production to meet the growing needs of chronic stroke patients.
Publications & Presentations
Peer-reviewed research and conference presentations supporting CC-101 development.
Clinical state and future directions of stem cell therapy in stroke rehabilitation
Habib P, Steinberg GK — Exp Neurol, 2025
View Publication →Decoding the molecular crosstalk between grafted stem cells and the stroke-injured brain
Azevedo-Pereira RL, Manley NC, Dong C, et al., Steinberg GK — Cell Rep, 2023
View Publication →Optimizing the success of cell transplantation therapy for stroke
Bliss TM, Andres RH, Steinberg GK — Neurobiol Dis, 2010
View Publication →Adherent self-renewable human embryonic stem cell-derived neural stem cell line: functional engraftment in experimental stroke model
Daadi MM, Maag AL, Steinberg GK — PLoS One, 2008
View Publication →