160 East 56th 3rd floor New York
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Dr. Dreschnack Bells Palsy Research

Dr Paul Dreschnack is conducting a study on the use of Extracellular vesicles (ECV’s) for the treatment of established Bell’s Palsy. Specifically, we are investigating if donated extracellular vesicles (ECV’s) infused into your bloodstream that can assist the restoration of nerve function in your face.

The purpose of the research Bell’s Palsy is a disease that affects about 40,000 people in the United States every year. Globally 0.02% of the population is affected. The complications of the disease can be devastating, including eye injuries, a loss of taste, facial drooping, and severe changes around the ear, just to name a few.

We are interested in studying how to improve the efficiency of your facial nerve and perhaps make your symptoms less severe. IN our research Intervention In this study we will inject Extracellular vesicles (ECV’s) in a vein in your arm, just like a regular IV line in a hospital. We will treat you several times over a term of the study. A second injection will be required into your facial nerve area to reduce swelling in the facial nerve. The goal of the study is to see if your neurological symptoms can be improved, and nerve function made more efficient.

Your condition will be monitored by our study staff that will have access to your online data. Participant selection We are inviting patients with diagnosed facial nerve paralysis to participate in this study, and have regular examinations to collect data to participate in this study.

The ECVs we use are from Direct Biologics’ ExoFlo™ extracellular vesicles (ECV’s) ; they are isolated from human bone marrow mesenchymal stem/ stromal cells (MSCs). Extracellular vesicles (ECV’s) are not cells. They do not contain DNA.

Extracellular vesicles (ECV’s) are known to promote healing and decrease inflammation directly in tissues. The use of Exoflo Extracellular vesicles (ECV’s) has been approved by the FDA in a previous study treating COVID-19 patients under an IND (Investigational New Drug).

Our procedures and protocol is for initially all patients will receive a medical evaluation. This may be completed by your primary physician or a cardiologist. Basic labs will be ordered that are part of your routine exams and monitoring. This would include a Complete Blood Count, Comprehensive Metabolic Profile, CT’s or MRI’s of the body. Extracellular vesicles (ECV’s) will be administered to 10 patients intravenously during weeks 1, 2 and 4 of treatment. The same 10 patients who will receive Extracellular vesicles (ECV’s) intravenously, will be treated with an ECV injection into the tissue around the affected facial nerve. You will continue to take your medications as prescribed by your physician. Data will be collected and analyzed for the study results. You will be monitored for 1 month. Labs will be repeated as required during and upon completion of the study.

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