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MEDICAL RESEARCH AT RESTORE HEALTH CENTER

Why are we doing research?
Many wonderful therapies don’t find their way to the people who need them because the therapies are not well known or they lack acceptance by the general medical community. Regenerative therapies that target our own body’s ability to heal lack the huge funding behind pharmaceutical treatments, which leads to a scarcity of the research needed to advance the development and implementation of these therapies.

By working under the direction of the Institute for Regenerative and Cellular Medicine Institutional Review Board (IRB) we hope to gather well thought out and peer reviewed data leading to publication in scientific journals and eventually further development and acceptance of Regenerative Medicine modalities.

Regenerative Medicine product being studied.
We are currently studying two applications of the same product produced by Direct Biologics (ExoFlo). This product is produced by harvesting the tiny signaling molecules made by a specific set of bone marrow derived stem cells immortalized in tissue culture. These tiny signaling molecules, or Extracellular Vesicle Isolate product, has been shown to be the mechanism behind the beneficial effects produced by stem cell treatments in general. But in contrast to stem cells, which vary in viability and activity from person to person, these Extracellular Vesicles can be concentrated and standardized so as to produce a more consistent result from treatment to treatment, which is why we are currently using this product for joint injections with more consistent success than when we inject actual stem cells into the joint.

This product has also been studied in a number of applications including the treatment of auto-immune disorders like MS and rheumatoid arthritis. The FDA has recently granted a third IND (Investigational New Drug) to this product to be studied in the treatment Acute COVID-19 Syndrome and Chronic post-COVID-19 Syndrome.

For further information on this product see: https://directbiologics.com/

CURRENT STUDIES

DETAILS ON NON ALCOHOLIC FATTY LIVER DISEASE  (NAFLD) STUDY

We are currently studying two novel applications of these Extracellular Vesicle Isolate Product (ExoFlo).

  1. In Non Alcoholic Fatty Liver Disease (NAFLD) as a single IV infusion while monitoring liver function tests and liver ultrasounds before and after treatment.
  2. In Chronic Obstructive Pulmonary Disease (COPD) as a series of two nebulized treatments scheduled a week apart while monitoring symptoms and pulmonary function tests before and after treatments.

Overview of NAFLD
According to the American Liver Foundation NAFLD is the most common cause of liver disease and affects 30% of the US population and 73% of type II diabetics.

There are no medications to treat NAFLD and over time it can silently progress to non alcoholic steatohepatitis (NASH) leading to cirrhosis of the liver. NAFLD is rapidly becoming a common cause of Hepatocellular Carcinoma.

Participation requirements
Participants in this study must have a diagnosis of NAFLD and be willing to have blood work and a liver ultrasound prior to treatment as a baseline followed by repeat blood work and liver ultrasounds at 6 weeks, 3 months and 6 months post treatment.

Treatment details
The treatment will consist of one ten ml infusion of the Extracellular Vesicle Isolate Product (ExoFlo) from Direct Biologics while being monitored at our office.

Cost for participating
There will be no cost to you for participating in the study.

Consent to participate in the study
Click here to review consent

DETAILS ON CHRONIC OBSTRUCTIVE PULMONARY DISEASE  (COPD) STUDY

Overview of COPD
COPD is a term used to describe chronic lung diseases including emphysema and chronic bronchitis which are most commonly caused by smoking.  COPD is typically treated with inhalers including anti-inflammatory medications and bronchodilators. Although the symptoms can be controlled with medications COPD is not typically cured or reversed with current treatments.

Participation requirements
Participants in this study must have a diagnosis of COPD and be willing to undergo Pulmonary Function Testing at our office prior to treatments as a baseline as well as at 6 weeks, 3, 6 and 12 months after the treatments. Participants must also agree to filling out a COPD Assessment Test (CAT) questionnaire at the same intervals.

Treatment details
The treatment will consist of two nebulized treatments consisting of 5 ml of the Extracellular Vesicle Isolate Product (ExoFlo) from Direct Biologics spaced one week apart.

Cost for participating
There will be no cost to you for participating in the study.

Consent to participate in the study
Click here to review consent

How to participate in our studies.

If you have either one of the conditions being studied, and are interested in participating in one of the studies, please review the attached study details and consent forms first. If after reviewing the materials you would like to participate in the study, please email studies@restorehealthcenter.net to begin the application process.

There will be no cost to you for participating in the studies.

Published Studies using the same Extracellular Vesicle Isolate Product (Exoflo) from Direct Biologics which we are using in our studies.

Location

Restore Health Center

3553 Clydesdale Pkwy., Suite 230
Loveland, Colorado, 80538

Phone: (970) 278-0900