Question 1

Is CC-101 made from a patient's own cells?

Accepted Answer

No. CC-101 is allogeneic — every dose comes from a single donor master cell bank, so every patient receives the same, consistent product. There is no waiting period for personal cell processing or donor matching.

Question 2

Can the company make enough therapy to reach the patients who need it?

Accepted Answer

Yes. CC-101 is off-the-shelf and cryopreserved, manufactured from one master cell bank at modest scale. CC-101 production can be scaled up and out to meet commercial needs. The model was designed from the start to serve those living with chronic ischemic stroke.

Question 3

How soon can someone go home after the CC-101 transplantation procedure?

Accepted Answer

The procedure is designed to allow patients to return home as early as 6–8 hours after transplantation. This is anticipated to be “same day” in most cases.

Question 4

Has CC-101 been studied in people?

Accepted Answer

Yes. A Phase 1/2a human clinical trial involved 18 subjects with chronic ischemic stroke. CC-101 (called NR1 in the study at Stanford) was generally well-tolerated and produced meaningful and durable improvements in motor function in the majority of subjects. Our Phase 2b study begins this year in a larger population of subjects and at multiple hospitals in the U.S.

Question 5

Is CC-101 approved by the FDA?

Accepted Answer

No. CC-101 is an investigational therapy that has not been approved by any regulatory authority. The regulatory path includes Phase 2b, a Phase 3 pivotal study, and a Biologics License Application — with potential approval and commercial launch in the future.

Question 6

What if my stroke happened years ago — am I too late?

Accepted Answer

CC-101 is designed for chronic stroke, not acute stroke. In Phase 1/2a, subjects were treated a median of 33 months after their stroke, with a range of 8 to 61 months. The treatment is being studied for patients between six months and seven years post-stroke.

Question 7

How does CC-101 help the brain recover?

Accepted Answer

Once transplanted adjacent to the damaged area, the cells secrete trophic factors — a complex mix of growth signals — that we believe activate the brain's own dormant neural stem cells. Those native cells then differentiate into the neurons and supporting cells needed to rebuild lost connections. CC-101 functions more like fertilizer than seed.

Question 8

How can a patient enroll in a Clarion Cells trial?

Accepted Answer

Trial details and key enrollment criteria can be found on [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07709845). For specific questions, the clinical team can be reached through our contact form.

Frequently Asked Questions

Frequently Asked Questions