INTRODUCTION

Umbilical cord blood presents as a prolific source of cells, signaling proteins, and growth factors with potential benefits for use in Regenerative Medicine (Damien and Allan 2015). Highly oxygenated blood, rich in nutrients, is transferred from the placenta to the fetus via the umbilical cord. This cord blood is replete with many stem, immune and progenitor cells, in addition to proteins and growth factors that support healthy growth of the fetus (Riordan 2007). Often discarded, umbilical cord blood is now frequently recovered and cryopreserved to be stored by mothers and researchers in public and private cord blood banks (Riordan 2007).

BACKGROUND

Cord blood banking and transplantation has nearly a 30-year history with thousands of cord blood transplants having been performed in patients with hematopoietic malignancies, marrow failure and immunodeficiency disorders (Ballen, Gluckman, Broxmeyer 2013). Cells derived from umbilical cord blood have unique characteristics that enable regenerative medicine techniques and applications without the requirement to perfectly match tissue types (Riordan 2007). Umbilical cord blood contains hematopoietic stem cells (HSC), mesenchymal stem cells (MSC), and endothelial cells (Roura, Pujal, Galvez-Moon 2015). MSCs can help with inflammation modulatory response, release various growth factors, and can help supplement various connective tissue repair needs. Endothelial stem cells will form the lining of blood and lymph vessels and help vascularize tissue, making endothelial cells an increasingly compelling interest in the orthopedic applications (Atesok et al. 2012) and ischemic damage (Au et al. 2008). Cord blood stem cells are being observed for their trophic role, supplying growth factors, exosomes, cell-cell signaling, and immunomodulatory factors (Damien and Allan 2015; Rizk, Aziz, Shorr 2017). With these types of paracrine and autocrine effects on stimulating the body’s own ability to heal and regenerate (Rizk, Aziz, Shorr 2017), various applications are under wider investigation (orthopedic, neurological, immune modulation, etc.).

The uses of cord blood stem cells and growth factors in regenerative medicine are vast and emerging. The cord blood is recovered from live healthy birth donors of consenting mothers, then process and preserve the cord blood using a proprietary process to maximize the available biocellular and growth factor elements for safe allogeneic use. This Product Characterization

Report demonstrates the concentration, characterization, and quality of StemShot® – Umbilical Cord Blood Cellular Suspension Allograft.

METHODS & RESULTS

Umbilical Cord Blood Collection
Umbilical cord blood used in the StemShot® product is recovered from consenting mothers (donors) who deliver live-birth C-sections within a sterile operating room. Cord blood is collected at the time of birth via venipuncture of the umbilical vein and maintains sterility throughout the recovery process. All donors are screened and tested to ensure they meet the established FDA requirements for donating their post-natal birth tissue. An evaluation, performed by the manufacturer’s medical director, is performed to ensure there are no risks related to the donated birth tissue. The assessment includes a review of the donor’s medical history, health status, and personal behavior. A physical evaluation of the donor is also performed before delivery to ensure the mother is in good health. All donors are tested for infectious disease, as required by the FDA, including: HIV, HTLV, Hep B, Hep C, Syphilis, CMV, West Nile Virus, and Lyme disease. All post-natal birth tissue donations are identified with a unique donor identification number to ensure it can be tracked from the recovery / collection process and linked to the finished product for tracing, including storage and distribution.

Laboratory Processing
The donated umbilical cord blood is aseptically processed to ensure it is safe and effective for patient use. A sample from each manufactured lot, aligning with USP 71, is tested for sterility by a third-party lab. Additionally, aerobic and anaerobic testing is performed during manufacturing each lot to ensure the environment and product is free from bacteria, fungus, etc. The manufacturing process has been validated to remove 99.99% of red blood cells, while retaining the desirable cells and growth factors for optimal end product. The processed product is cryopreserved in a way to maximize the safe preservation of cellular and growth factor material into a fully suspended cryo state.

Cell Characterizations & Viability
3rd party testing – A sample of manufactured umbilical cord blood was tested by an independent third party, Franciscan Institute for Science and Health, for live nucleated cell counts and live cells. A rapid thawing protocol was used that aligns with the technique that the healthcare professional would use when administering the product. The protocol required the tester to hold the vial in a gloved hand until the frozen contents became liquid (under 5-minute thaw time). Measurements of the cell number, cell viability, and cell size were determined using a Nexcelom Cellometer (Figure 1). The total nucleated cells (TNC) was determined by staining with (AO/PI) acridine orange and the number of dead cells was determined by staining with propidium iodide. The viability rate or percent of viable cells was then calculated.

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