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Autologous Stem Cell Therapy Development for the Brain

Regeneration Biomedical, Inc., of Newport Beach, CA, leverages world-class capabilities in stem cell therapy development and clinical application. Our research focuses on Alzheimer’s Disease, ALS, Multiple Sclerosis, Parkinson’s disease and its variants, stroke, and traumatic brain injury (including chronic traumatic encephalopathy (CTE). Because all of these diseases are neurodegenerative, the best way to attack them is by injecting stem cells directly into the brain. The technique we developed places the stem cells where we think they need to be, to achieve the ultimate efficacy. We are seeking private, VC, and corporate funding for moving into Phase 1/2 FDA trials for these deadly diseases with no current curative therapies.

Company Overview

Leadership

Our company is at the forefront of the biomedical research industry thanks to professionals who have had more than 30 years of medical and research experience.

ABOUT US

Process

We believe that a patient’s OWN stem cells (autologous) have the power to heal. Other stem cell technologies are using umbilical, fetal, embryonic and other allogeneic cells (from other donors or banks), which in and of themselves have…

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Product

Our proprietary therapy is derived from a patient’s own fat cells, which is a First-in-Class Adipose-Derived Stem Cell population. We use a proprietary isolation-expansion-enrichment manufacturing protocol to synthesize the therapy and inject it directly into the brain.

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Past Research

Our preliminary work was essentially a Phase 1 safety trial in humans performed with IRB approval. We were not looking for clinical efficacy. However, secondary endpoints such as improvement in their conditions were certainly optimistic and have acted…

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FDA Clinical Trials

After two years of diligent collaboration with the FDA (conducting a requested large animal safety study, presenting them with all of our past IRB approved human trial work, meeting all of their requirements, and satisfying all of their questions), Regeneration Biomedical received clearance to begin our Phase 1 Safety Trial of our product CEREWINT. Our Phase 1 Safety Trial will be conducted at Hoag Hospital Newport Beach. To view the trial details click here.

CEREWiNT® Phase 1 Clinical Safety Trial
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About Us

Founder Christopher Duma, MD, FACS and his advisor Hans Keirstead, PhD have been doing human pre-clinical work for this endeavor for 5 years. However, Dr. Duma has 30 years of brain surgery experience and Dr. Keirstead has 30 years of stem cell research experience. From the start, Dr. Duma’s goal was to develop a technique for injecting stem cells directly into the brain. His cell preparation and injection technique is patent pending.

(877) 240-1660

“Modern medical advances have helped millions of people live longer, healthier lives. We owe these improvements to decades of investment in medical research.”

Ike Skelton

Investment Opportunities

Venture into the biomedical research market or extend your reach into it by investing in RBI, Inc. Your funding will help us continue making inroads into the field of stem cell research and treatments. Contact us for additional details about investing.

The global center nervous system therapeutic market was worth USD 77.2 billion in 2016 and is anticipated to grow at a CAGR of 5.9%

Contact

Thank you for your interest. We look forward to hearing from you soon.

3900 West Coast Hwy Suite 300 Newport Beach California 92663 | Phone: 1-877-240-1660 Fax: 1-949-480-0657
© Copyright  Regeneration Biomedical, Inc. All Rights Reserved.
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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:

    1. 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.
    2. 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.
    3. 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®”.
    4. 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.
    5. 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.***
    6. The Participant will remain in the hospital over-night, be monitored for 24 hours, and have a next day visit with their surgeon.
    7. 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.
    8. 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.
    9. 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

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