Expanded Access Policy

Expanded Access Policy2024-01-18T05:14:09+00:00

Regeneration Biomedical Expanded Access Policy

Expanded access, also known as “compassionate use” is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. These investigational drugs have not yet been approved or cleared by regulatory bodies like the FDA, and these products have not yet been found to be safe and effective for their specific use.

Regeneration Biomedical, Inc.’s investigational product, RB-ADSC, is being evaluated in early clinical trials for Alzheimer’s Disease. More clinical studies are required before “compassionate use” can be considered, therefore, RBI does not currently offer an expanded access program for RB-ADSC. The most appropriate way for patients to access RB-ADSC is by participating in our clinical trial. Information regarding the ongoing clinical trial can be accessed at www.clinicaltrials.gov (Identifier: NCT05667649).

If you have any questions regarding potential participation in RBI’s clinical trial or about this expanded access policy, please contact us.

As authorized by the 21st Century Cures Act, RBI may revise this policy at any time.

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