The University of Health and Spiritual Sciences™️ In conjunction with the University of Integrative Medicine™️ proudly presents therapeutic clinical FDA and Institutional Review Board approved protocols under which practitioners can utilize one of the greatest developments in Regenerative and Restorative Medicine. This is the use of stem cells as a part of your approved therapeutic clinical research protocols.
The FDA oversees tissue transplant products, including stem cells, and enforces rigorous industry standards to ensure patient safety. When cellular and tissue products meet the FDA’s established criteria, they are designated as HCT/P 361 products rather than being classified as drugs. Although these products are subject to FDA regulation, they do not undergo the full FDA approval process. This makes it crucial to select companies with a transparent and well-documented history of FDA interactions when procuring these products.
Recognizing the potential of stem cell therapies to treat a variety of medical conditions, the FDA has implemented stringent regulatory measures. Manufacturers are regularly reviewed to ensure compliance with established protocols. During these inspections, investigators are required to provide detailed insights into their manufacturing processes, allowing the FDA to confirm that all necessary steps are being taken to ensure the product’s safety, purity, and efficacy.
While the exact mechanisms behind cellular therapies—renowned for their potential to deliver lasting healing—remain not entirely understood, a wealth of anecdotal evidence and numerous case studies are gradually shedding light on this intricate and promising field. Because biologic grafts, cellular therapies, and tissue products consist of a vast array of molecules and complex structures, fully deciphering how well-executed regenerative treatments work will require time and continued research.
Always prioritizing safety, the UHSS™️ special clinical IRB research protocol will keep driving forward our understanding of these mechanisms and best practices in regenerative and restorative medicine. In the meantime, buoyed by our exceptional safety record, we are excited to see these therapies continue to benefit physicians committed to advancing care for their research participants. The UHSS™️ research directors as part of our Acu Stem Technique™️ and protocols will remain diligent in collecting and analyzing data to further unlock and maximize the potential of regenerative and restorative medicine. The benefit to the clinical researcher who is involved with The UHSS™️ therapeutic clinical research methodologies is that all your data is privileged, confidential and protected by law, giving you a distinct advantage and privacy over other research methodologies available.
Mesenchymal Stem Cells (MSCs) are self-renewing, multipotent progenitor cells capable of differentiating into various cell types and tissues. Research shows that MSCs are present in numerous tissues throughout life; however, their numbers and functional characteristics tend to decline with age, with older MSCs often behaving differently than those from younger sources. Despite these changes, MSCs remain highly promising, whether sourced from an individual’s own aging cells or from postnatal tissues.
Moreover, MSCs exhibit significant indirect local effects—comparable to paracrine activity—that can persist for several weeks or more. They appear to adapt to their surrounding environment, acting much like revitalized defenders that can stimulate targeted regeneration when the host cells have lost their full capacity to do so.
Notably, postnatal tissues boast high concentrations of MSCs across various compartments. These cells are characterized by a more robust secretome, quicker cell division, and a lower propensity for teratoma formation, underscoring their enhanced therapeutic potential.
Totipotent Stem Cells
Totipotent cells—often referred to as embryonic stem cells—possess the extraordinary ability to develop into any cell type or tissue, including extraembryonic structures like placental cells. While this remarkable potential suggests vast opportunities, the significant risk of teratoma formation renders these cells unsuitable for therapeutic applications, and their use is prohibited in the United States.
Pluripotent Stem Cells
Pluripotent stem cells can transform into any cell type in the body, giving rise to tissues derived from all three embryonic germ layers: endoderm, mesoderm, and ectoderm.
Multipotent Stem Cells
Multipotent stem cells, while capable of generating various cell types, have a more limited differentiation potential compared to pluripotent cells. They can be found in postnatal tissues such as the umbilical cord and placenta, as well as in adult tissues, serving as a vital reservoir for growth and repair. Each type of multipotent stem cell differentiates into a specific subset of cells. Although isolating these cells for clinical applications can be challenging, they are considered ethically sound. Examples include hematopoietic stem cells (HSCs) and mesenchymal stem cells (MSCs).
MSC's in Postnatal Tissues
MSC’s were first identified in the adherent fraction of bone marrow stroma. They were termed CFU-Fs because of their ability to generate single cell-derived colonies, in analogy to their hematopoietic counterparts, CFU-Fs from almost all embryonic and postnatal tissues can be expanded in vitro to generate cell cultures that conserve trilineage potential. The role of MSC’s in multiple anatomical locations, and whether they constitute a specific homogeneous cell type or a mixed population of tissue-specific cells heterogenous in nature and origin, is not well understood. However, these progenitors express pericyte-specific cell-surfaced markers such as NG2 and PDGRRB and are located in perivascular regions of the different tissues in which they reside.
MSC Expansion in Vitro
Mesenchymal stem cells (MSCs) can be expanded in vitro by culturing them as adherent cells in two-dimensional monolayers using specialized media. Our specialized research based methodologies utilize the best of technology to provide cells which are superior is quality and quantity. These expanded cells, often referred to as multipotent mesenchymal stromal cells, are characterized by the expression of markers CD73, CD90, and DC105, while lacking CD11b, CD19, CD34, CD45, and HLADR. In this context, we refer to the in vitro-expanded cells simply as mesenchymal stromal cells.
MSC Differentiation Potential
The primary characteristic of multipotent mesenchymal stromal cells is their ability to differentiate into mature adipocytes, chondrocytes, and osteoblasts under specific culture conditions. Our cells which have been specifically harvested, cultured and selected for our research protocols exhibit unique cell signaling and paracrine properties. Their level of safety and efficacy are clearly above industry standards. They have specifically designated for therapeutic clinical research under strict Institutional review board scrutiny and analyses.
The UHSS™️ Acu Stem Technique™️ protocol incorporates a rigorous quality program aimed at preventing, identifying, and rectifying any deficiencies that could elevate the risk of introducing, transmitting, or spreading communicable diseases. This quality program covers all products, services, and researchers at The UHSS™️, as well as relevant contracted service providers.
These are cells having been prepared using proprietary technology and possessing unique characteristics which have been designated to be used for therapeutic clinical research under approved IRB’s in conjunction with the University of Health and Spiritual Sciences™️ and University of Integrative Medicine™️ clinical Institutional Review Board consortium.
Additionally, our product processing entities adhere to the FDA’s minimal manipulation requirements, ensuring that the products remain free of contaminants or harmful components, while preserving the essential biological characteristics of the cells and tissues.
Homologous Use
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for transplantation, infusion or transfer into a human recipient to assist in the body’s natural regenerative functions.
These products are cells / nonstructural tissues that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune and endocrine functions.
The products we utilize in our IRB approved therapeutic research clinic protocols are intended for homologous use, on a single patient, one time use only. They can be approved to be used by licensed healthcare providers under strictly monitored clinical research protocols.
The Effects of Secretion Factors from Umbilical Cord Derived Mesenchymal Stem Cells on Osteogenic Differentiation of Mesenchymal Stem Cells
Co-transplantation of third-party umbilical cord blood-derived MSCs promotes engraftment in children undergoing unrelated umbilical cord blood transplantation
