Expanded Access Program
StemCyte's compassionate use framework for investigational therapies.
What is expanded access?
Expanded access (compassionate use) allows patients with serious or life-threatening conditions to receive investigational therapies outside clinical trials when no comparable treatment exists.
StemCyte's program covers three pathways (EAP, emergency IND, and single patient access), each evaluated individually per FDA regulations.
Long COVID
In early clinical results, 85% of participants saw fatigue improvement, compared to 20% with placebo. For patients who cannot join Phase III trials.
ClinicalTrials.gov →Who qualifies?
Patient
Has a serious or life-threatening condition with no satisfactory alternative treatment
Is ineligible for any ongoing clinical study of the product, including due to geographic limitations
Has not received any cell-based therapy within the past 12 months
Clinical assessment determines that potential benefits outweigh the risks
Agrees to comply with all study requirements and complete all scheduled visits
Product
Is under clinical investigation in one or more trials with high safety profiles
StemCyte has adequate supply to support expanded access
Providing access will not interfere with completing clinical trials or delay marketing approval
Physician
Must be properly licensed in their jurisdiction
Must meet all applicable country-specific legal and regulatory requirements
Must be qualified and experienced in cord blood or stem cell infusion
Must agree in writing to comply with safety reporting and IP protection requirements
How to request access
Requests are always initiated by the treating physician.
Contact
Physician emails clinical team with patient details
Acknowledge
Receipt confirmed within 10 business days
Evaluate
Case-by-case review per FDA regulations
Coordinate
Delivery via appropriate pathway
As authorized by the 21st Century Cures Act, StemCyte may revise this expanded access program at any time. The posting of this program shall not serve as a guarantee of access to any specific investigational drug by any individual patient. Expanded access is subject to FDA regulations and is evaluated on a case-by-case basis. Clinical outcomes are not guaranteed.
Submit an expanded access inquiry
Requests are typically initiated by the treating physician. Patients and caregivers — please share this page with your care team to start the conversation.
Let's continue this in email
Expanded Access requests go through a dedicated channel so we can respond carefully and confidentially. Send us a note and we'll follow up — typically by phone — to discuss your situation.