---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-007079"
form_type: "8-K"
ticker: "CCEL"
cik: "0000862692"
company_name: "CRYO CELL INTERNATIONAL INC"
filed_at: "2023-03-09T23:59:59+00:00"
generated_at: "2026-06-18T08:03:36.004068+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Cryo-Cell amends Duke license, adds milestone for autism MSC therapy; funds IMPACT study

## Summary
- Second Amendment removes final license fee payment to Duke; license fee now paid in full.
- New milestone payment triggered upon FDA approval of first cord tissue MSC product for autism spectrum disorder.
- New milestone requires Cryo-Cell to open manufacturing facility for licensed product before Phase III trial initiation.
- Cryo-Cell entered Research Agreement to fund Duke IMPACT Study; 14 monthly payments starting April 2023.
- IMPACT Study targeted accrual reached: 137 patients; draft publication due no later than September 30, 2024.

## SEC filing metadata
- accession: 0000950170-23-007079
- form_type: 8-K
- ticker: CCEL
- cik: 0000862692
- company_name: CRYO CELL INTERNATIONAL INC
- filed_at: 2023-03-09T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 1.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/862692/000095017023007079/0000950170-23-007079-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/862692/000095017023007079/ccel-20230303.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-007079
- JSON: https://secwatch.observer/filing/0000950170-23-007079.json
- Plain text: https://secwatch.observer/filing/0000950170-23-007079.txt

## Key facts
- Material Agreements
  CRYO CELL INTERNATIONAL INC entered into Clinical Study and Research Agreement with Duke valued at 14 equal monthly payments commencing in April 2023 and a final payment (effective 2023-03-03).
  - Action: entry
  - Agreement: collaboration
  - Counterparty: Duke
  - Value: 14 equal monthly payments commencing in April 2023 and a final payment
  - Effective: 2023-03-03
  source text: As part of the Second Amendment, on March 3, 2023, the Company entered into the Clinical Study and Research Agreement (the “Research Agreement”) with Duke to provide funding to complete the Duke IMPACT Study
  evidence_url: https://www.sec.gov/Archives/edgar/data/862692/000095017023007079/0000950170-23-007079-index.htm
- Material Agreements
  CRYO CELL INTERNATIONAL INC amended Second Amendment to the License Agreement with Duke (effective 2023-02-17).
  - Action: amendment
  - Agreement: license
  - Counterparty: Duke
  - Effective: 2023-02-17
  source text: On February 17, 2023, Cryo-Cell International, Inc. ("Company") entered into a Second Amendment to the License Agreement (the “Second Amendment”) with Duke
  evidence_url: https://www.sec.gov/Archives/edgar/data/862692/000095017023007079/0000950170-23-007079-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.