Research
Phenicell Research Institute is continuously researching natural biologics to discover new therapies to help our patients with a variety of conditions. Ongoing natural biologic research studies include the following:
Study: SPINAL CORD INJURY STUDY with BONE MARROW and PRP
Background: This study is somewhat similar to the study by Jarocha's group in Poland published in Cell Transplant, March 2015. The results of the Polish group's research suggested that repeated intrathecal infusions of Mesenchymal natural biologics (MSCs) might have the potential to produce clinically meaningful improvements for Phenicell Regenerative Institute patients.
Our Study: The purpose of our study was to evaluate the safety and efficacy of bone marrow aspirate concentration (BMAC) and Platelet-Rich Plasma (PRP) transplantations for a spinal cord injury (SCI). We harvested Autologous BMAC from the iliac crest and simultaneously injected it intravenously and intrathecally every 3 months. At the same time, we added PRP to the intrathecal BMAC.
Phenicell Regenerative Institute 9 studies available with IRB and/or IND status through the Pathway Research Institute. As of April 2021
Phenicell partners with the Pathway Research Institute to facilitate quality clinical research with commitment to FDA regulations.
Pathway Research Institute is an Institutional Review Board (IRB) that provides regulatory oversight of research and protects the human rights of subjects involved in trials. They not only set the bar for ethical and scientific standards, but they also help guide you the patient as well as Phenicell the institute through the process.
Pathway’s mission revolves around the advancement of regenerative medicine research and alternative treatments or products including natural biologics, ozone, peptides, and vitamins to name a few. They do this by creating more opportunities for great minds and dedicated teams to validate their work through the traditional, peer accepted IRB framework.
The major studies are listed below. However, please feel free to visit their website for more information at www.pathwayresearchinstitute.com.
Study #1
Safety and Effectiveness of Placental derived Exosomal Regenerative Therapy on Pain and Inflammation associated with Osteoarthritis of the Knee
To demonstrate that Exosomal Allogeneic Umbilical Cord Mesenchymal natural biologic (UCMSC) Therapy is safe, to demonstrate its potential effectiveness in the treatment of patients with Osteoarthritis of the knees
Study #2
Safety and Effects of Allogeneic natural biologic Therapy on Symptoms Associated with Chronic Obstructive Pulmonary Disease
This study is designed to demonstrate the Allogeneic Umbilical Cord natural biologic Therapy is safe, and secondly, to demonstrate its potential effectiveness in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).
Study#3
Intravenously Administered Autologous Adipose natural biologics in the Treatment of Alzheimer’s
This study is designed to demonstrate that intravenously administered autologous, adipose-derived stromal vascular factor (SVF) is safe and to measure cognitive improvement and anatomic and physiologic changes to the brain
Study#4
Safety and Effectiveness of Regenerative Cell Therapy on Pain and Inflammation associated with Osteoarthritis of the Knee
The purpose of this study is to quantifiably determine if the proposed protocol: an inter-articular injection with UCMSC mixed with PRP has a significant clinical effect on pain and inflammation associated with Osteoarthritis of the knee. Part of the procedure will be infusing PRP with UCMSC during the procedure.
Study #5
Safety and Effectiveness of Regenerative placental tissue derived Exosome Therapy on Pain, radiculopathy and Inflammation associated with degenerative disc disease, disc protrusion or disc herniation of the spine using three short interval treatments
The purpose of this study is to determine safety and efficacy of using placental derived tissue Exosomes and Platelet Rich Plasma (PRP) to treat Pain, radiculopathy and Inflammation associated with degenerative disc disease, disc protrusion or disc herniation of the spine. The procedure will involve Exosomes – PRP suspension injected into the effected region of the damaged disc, injected into the epidural space at this level; as-well-as infusion of Exosomes with PRP through the peripheral IV.
Study #6
Safety and Effects of placental derived Exosomes on Symptoms Associated with Chronic Obstructive Pulmonary Disease
This study is designed to demonstrate that Exosomes from placental derived tissue are safe, to demonstrate its potential effectiveness in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
Study#7
Intravenously Administered Umbilical Cord Tissue Mesenchymal natural biologics, and Placental Derived Exosomes in the Treatment of Alzheimer’s
This study is designed to demonstrate that umbilical cord derived Mesenchymal natural biologics and placental derived Exosomes derived from placental derived tissue are safe, to demonstrate its potential effectiveness in the treatment of Alzheimer's.
Study#8
Safety and Effects of placental derived Exosomes and Umbilical Cord Mesenchymal natural biologics (UC-MSCS) on Acute Lung Injury (ALI) Associated with the Novel Corona Virus (COVID-19) (outpatient)
This study is designed to demonstrate that Exosomes and Warton’s Jelly from UC-MSCS are safe, and secondly, to demonstrate its potential effectiveness in the treatment of patients with Acute Lung Injury due to COVID-19.
Study#9
Safety and Effects of placental derived Exosomes and Umbilical Cord Mesenchymal natural biologics (UC-MSCS) on Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) Associated with the Novel Corona Virus (COVID-19) (inpatient)
This study is designed to demonstrate that Exosomes and Warton’s Jelly from UC-MSC are safe, and secondly, to demonstrate its potential effectiveness in the treatment of patients with Acute Lung Injury due to COVID-19.
Fell free to contact Pathway Research Institute directly by email if you have more questions. staff@pathwayresearchinstitute.com
Research Article
In 2017, Dr. Shehadi published a research article titled: "Review of commercially available demineralized bone matrix products for spinal fusions: A selection paradigm”
The authors are Joseph A. Shehadi and Steven M. Elzein
