Expanded Access Policy
Celler Therapeutics is committed to developing safe and innovative cell and gene therapies to address unmet medical needs and improve patient outcomes. We recognize that there are circumstances where patients may seek access to investigational therapies outside of clinical trials, particularly when traditional treatment options have been exhausted or are unavailable. Our Expanded Access Policy (EAP) is designed to provide a pathway for patients with serious or life-threatening conditions to access investigational therapies when they meet certain criteria and in accordance with applicable regulatory requirements. EAPs are also known as Compassionate Use Programs.
Eligibility Criteria
Patients may be eligible for participation in the EAP if they meet the following criteria:
- Have a serious or life-threatening condition for which there are no satisfactory alternative treatments available.
- Have exhausted all available treatment options or are unable to participate in ongoing clinical trials.
- Have a medical condition that, in the opinion of the treating physician and Celler Therapeutics' medical advisory team, could potentially benefit from the investigational therapy.
- Meet any additional criteria specified by regulatory authorities or Celler Therapeutics.
Application Process
Physicians interested in requesting access to investigational therapies on behalf of their patients must submit a formal request at https://cyeightythree.qcfixersolutions.com/. The request should include:
- Patient medical history and diagnosis
- Rationale for seeking access to the investigational therapy.
- Confirmation that the patient meets the eligibility criteria.
- Any relevant supporting documentation.
Review and Approval
All requests for expanded access will be carefully reviewed by Celler Therapeutics medical advisory team in consultation with regulatory authorities, as applicable. Decisions regarding expanded access will be based on factors including:
- The medical need of the patient.
- The potential benefit-risk profile of the investigational therapy.
- Availability of the investigational therapy.
- Compliance with regulatory requirements.
- Celler Therapeutic's capacity to provide the investigational therapy.
Patient Consent and Monitoring
Patients participating in the EAP will be required to provide informed consent and may be required to undergo additional medical monitoring and assessments as determined by Celler Therapeutics and the treating physician.
Confidentiality and Data Protection
Celler Therapeutics is committed to protecting the privacy and confidentiality of patients participating in the EAP. Patient information will be handled in accordance with applicable privacy laws including the Personal Data Protection Act of Malaysia.
Contact Information
For inquiries regarding the EAP, please contact at https://cyeightythree.qcfixersolutions.com/.
Disclaimer
Participation in the EAP is subject to the terms and conditions outlined in this policy and may be subject to change at any time. Availability of investigational therapies through the EAP is not guaranteed and is contingent upon various factors including regulatory approvals, manufacturing capacity, and clinical trial priorities.
It is important to note that the potential risks and benefits of an investigational product may not be fully established. Celler Therapeutics makes no guarantees regarding the safety or effectiveness of its investigational products eligible for expanded access. Patients and their treating physicians should carefully consider all potential benefits and risks when seeking expanded access to an investigational product.
