Expanded Access Program of JointStem

Expanded Access Program of JointStem

On March 21, 2025, Nature Cell Co., Ltd. received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for JointStem, an investigational treatment developed using autologous adipose-derived mesenchymal stem cells for patients with severe knee osteoarthritis.

This designation allows Nature Cell to consider providing Expanded Access (EA) to JointStem prior to its formal regulatory approval. Accordingly, eligible patients may be able to access JointStem through one of the following two pathways: Participation in a Clinical Trial or Access through the Expanded Access Program (EAP).

Nature Cell prioritizes clinical trial enrollment, as these studies are specifically designed to evaluate the safety and efficacy of investigational treatments. The data collected from such trials is essential for regulatory review and plays a critical role in determining whether a therapy may be approved for general use.

However, in certain limited cases—such as when a patient is ineligible for participation in a clinical trial and has exhausted all other treatment options—access to JointStem may be considered under the Expanded Access Program (EAP).

EAP may be applicable to patients with serious or life-threatening conditions who meet specific criteria and for whom no satisfactory alternative therapies are available.

Nature Cell Approach to Expanded Access

Nature Cell will consider providing access to JointStem outside of a clinical trial only when all of the following conditions are met, in accordance with FDA guidance:

• Patient has a serious or immediately life-threatening disease or condition.
• There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
• Patient enrollment in a clinical trial is not possible.
• Potential patient benefit justifies the potential risks of treatment.
• Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

Expanded Access Approaches

Nature Cell currently provides Individual Patient Expanded Access under limited circumstances.

Access to JointStem for individual patients may be granted following a formal request from a licensed physician and only when all of Nature Cell’s EAP criteria are satisfied. The treating physician is responsible for overseeing all aspects of the patient’s care under the Expanded Access arrangement.

For more information about the FDA’s Expanded Access framework, please visit the (Expanded Access | FDA).

Requesting Expanded Access

Patients must first consult with their treating physician to determine eligibility for participation in Nature Cell’s Expanded Access Program.

If the physician determines, after clinical evaluation, that expanded access to JointStem is the only viable treatment option, they must submit a formal request to Nature Cell on behalf of the patient.

Requests will only be considered if the treating physician supports the use of the investigational therapy and is committed to conducting the necessary medical assessments as required by Nature Cell.

Once both the patient and physician have reviewed the relevant information and agree to proceed, the physician may contact Nature Cell at: 📧 smchung@stemcellbio.com

Nature Cell will review the request upon receiving all required medical documentation and a signed informed consent form from the patient. A formal response will be provided within 6 to 7 business days, although timelines may vary depending on the specifics of the case.

Alternatively, the physician may submit their contact information using the application form below. Upon submission, the request will be forwarded to the appropriate EAP representative at Nature Cell, who will respond within 6 to 7 business days.

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