Expanded Access Policy

Expanded Access Policyadmin2024-01-18T05:14:09+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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CEREWiNT® Phase 1 Clinical Safety Trial

Hoag Hospital – Newport Beach

The basic outline of our protocol is simple. Here are the steps a Participant will go through:

To be enrolled in Regeneration Biomedical’s Phase 1 Safety Trial for CEREWiNT®, a Participant must first be diagnosed by a physician to have Alzheimer’s disease and confirmed to meet all the Inclusion/Exclusion Criteria found on the Inclusion/Exclusion Criteria Page.
A Participant must have a designated caregiver that will help them get to and from their appointments and procedures. The Caregiver Inclusion/Exclusion Criteria can also be found on the Inclusion/Exclusion Criteria Page. All participants will meet with a physician or study coordinator and be given information regarding any risks, as well as a detailed explanation of all tests and procedures involved in the study and be required to give their own Informed Consent.
Once a Participant has been qualified as eligible, the participants will have their own personal fat cells collected via a lipoaspirate procedure (also known as liposuction – removing fat from the abdominal area) for processing. This will be done as an outpatient procedure at the Hoag Pavilion and will take about 1 hour. During processing, specific stem cells will be selected in a special (proprietary) way and prepared for the next steps. The cell processing takes about 4-6 weeks and at that point the finished product is called “CEREWiNT®”.
An Ommaya Reservoir will need to be implanted (if the Participant doesn’t already have one). An Ommaya reservoir is a flat-bottomed domed bubble which is implanted below the scalp. The reservoir is connected to a catheter which is placed into the hollow cavities of the brain through a hole made in the skull. Implantation of the Ommaya Reservoir and catheter is done via a brief outpatient surgical procedure which takes about 30 minutes.
About 8 weeks after collection, the cells will have been completely processed and will be ready for implantation. The Participant will come into the hospital or infusion center and have the reservoir area of their scalp prepped/sterilized for the procedure. After the Participant’s scalp is prepped, a surgeon will insert a small needle into the Ommaya Reservoir and draw out a small amount of cerebrospinal fluid. The surgeon will then inject the CEREWiNT® into the Ommaya Reservoir after which small amount of the cerebrospinal fluid that was drawn out will be used to flush the Ommaya Reservoir and get as much of the CEREWiNT® into the ventricles of the brain as possible. This entire procedure takes less than 30 minutes.***
The Participant will remain in the hospital over-night, be monitored for 24 hours, and have a next day visit with their surgeon.
The Participant will be monitored and tested for the next 52 weeks. This is a Phase 1 safety only trial. Each Participant will receive only one injection and safety will be assessed.
This Phase 1 Safety Trial lays the groundwork for Phase 2 efficacy trial. Participants in Phase 1 may have the option of rolling over into a parallel treatment group to the Phase 2 trial.
This document is for information purposes only; a more thorough informed consent will be given to the Participant prior to the start of the trial, for signature.

*** It is important to understand that there are risks involved in any safety trial. Some of the risks include bleeding, swelling, infection, discomfort, headache, and the possibility of additional surgery to name a few. A complete list of potential risks will be provided and completely explained to potential participants.

Inclusion Criteria