Our Commitment to Patients
Emmecell is committed to developing innovative regenerative cell therapies for patients with serious ophthalmic diseases. Our priority is to evaluate the safety and effectiveness of our investigational therapies through well-designed clinical trials so they can become broadly available to patients as quickly as possible.
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What is Expanded Access?
Expanded Access (also known as Compassionate Use) is an FDA regulatory pathway that may allow certain patients with serious or life-threatening diseases to receive an investigational product outside of a clinical trial when specific regulatory criteria are met.
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Emmecell's Current Policy
EO2002 and other Emmecell investigational products are currently being evaluated in clinical studies. At this time, Emmecell does not offer an Expanded Access Program. Participation in an appropriate clinical trial remains the preferred means of obtaining access to our investigational therapies.
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Why Expanded Access Is Not Currently Available
At this stage of development, Emmecell has limited manufacturing capacity, continues to collect essential safety and efficacy data, and must prioritize product supply for ongoing and planned clinical trials. Providing investigational product outside clinical trials could adversely affect clinical development and delay potential regulatory approval.
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Future Consideration
Emmecell may reconsider Expanded Access as our clinical programs and manufacturing capabilities mature. Any future program would be evaluated in accordance with applicable FDA regulations, available resources, manufacturing capacity, patient safety considerations, and the potential impact on clinical development.
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How Requests Are Evaluated
If Emmecell establishes an Expanded Access Program in the future, requests would generally be considered only when: the patient has a serious or life-threatening condition; no satisfactory therapeutic alternatives exist; the patient is unable to participate in an appropriate clinical trial; the potential benefits are judged to outweigh the risks; adequate product supply is available; and providing treatment would not interfere with ongoing clinical development.
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Physician Inquiries
Treating physicians seeking information regarding Emmecell clinical trials or future Expanded Access opportunities may contact the Company through the contact information available on www.emmecell.com. Requests should include relevant medical information and the rationale for considering investigational treatment.
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Clinical Trial Information
Information regarding ongoing Emmecell clinical studies is available at ClinicalTrials.gov.
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Policy Updates
Emmecell reserves the right to revise this policy at any time as our clinical programs, manufacturing capabilities, regulatory requirements, and scientific knowledge evolve. Publication of this policy does not create any obligation for Emmecell to provide investigational products through Expanded Access.