BHI Stemcells

Exosomes by Blue Horizon

Our research

Our research has been published in esteemed journals, including Experimental and Therapeutic Medicine (cited at PubMed Central, US National Library of Medicine, NIH) and CellR4, the official journal of The Cure Alliance. Notably, we have conducted the only long-term safety study published in US peer-reviewed literature, with our index patient dating back to 2017 and showing no significant side effects.

Our Exosomes

The exosomes are derived from WJ-MSC medium. The team, led by Brian Mehling, M.D., oversees all aspects of the operation from informed consent of the donor to cord procurement, processing and culturing the cord, harvesting the exosomes/extracellular vesicles from the growth medium to the final harvest of the WJ-MSCs.

Our Results

Our exosomes, derived from WJ-MSC medium, are produced under the meticulous oversight of Brian Mehling, M.D., ensuring high purity (>95%), scalability, and consistency across donors. These exosomes demonstrate strong regenerative and anti-inflammatory properties, verified through in-vitro assays, and meet rigorous safety standards with no contaminants detected.

What are Exosomes

Exosomes are nanoscale extracellular vesicles, ranging in size from 30 to 150 nanometers, that are secreted by virtually all cell types. These vesicles originate from the endosomal compartment within cells and are released into the extracellular environment, where they serve as highly efficient mediators of intercellular communication. Exosomes carry a diverse cargo of bioactive molecules, including proteins, lipids, messenger RNA (mRNA), and microRNA (miRNA), which they deliver to recipient cells, influencing a variety of cellular processes. Functionally, exosomes are pivotal in regulating immune responses, promoting tissue repair, and facilitating cellular regeneration. Their inherent ability to transfer functional biomolecules across biological barriers has garnered significant interest in the medical and scientific communities, positioning exosomes as a promising platform for therapeutic applications. Research has increasingly demonstrated their potential in regenerative medicine, oncology, and immunomodulation, underscoring their role as a next-generation tool for innovative treatment strategies.

Difference between
Stem Cells and Exosomes

To learn more about the key differences between stem cells and exosomes, watch the insightful video explained by Dr. Brian Mehling. In this video, Dr. Mehling provides a detailed comparison, highlighting the unique properties and therapeutic potential of each, shedding light on their roles in modern medicine. Don’t miss out on this informative explanation!

BHI Exosome Sources

Human Umbilical Cord-Derived Exosomes (hUCB)

Human Umbilical cord blood (hUCB)

Rich in a variety of bioactive molecules, including proteins, lipids, and RNA, which can be used to promote tissue regeneration and modulate immune responses.
Exosomes from human umbilical cord blood are an excellent source for non-hematopoietic applications, such as tissue repair and inflammation reduction, due to their low immunogenicity and ability to mediate regenerative processes.
These exosomes are also less likely to induce immune rejection, making them a favorable option for allogenic therapies without requiring HLA matching.

Autologous (obtained from the same individual) Exosomes

Adipose-Derived Exosomes

Exosomes derived from adipose tissue are easily harvested with minimal discomfort under local anesthesia, offering a non-invasive source for exosome isolation.
Adipose tissue contains a rich variety of mesenchymal stem cells (MSCs) that produce exosomes capable of promoting tissue regeneration, reducing inflammation, and enhancing wound healing.
These exosomes have been shown to be effective in musculoskeletal conditions, such as osteoarthritis and tendon injuries, by supporting cartilage repair, bone regeneration, and improving overall tissue function.
Adipose-derived exosomes are gaining traction as a promising therapeutic for both aesthetic applications (e.g., skin rejuvenation) and regenerative medicine.

BHI Stem Cell Quality And Research

We prioritize the highest standards of quality in the production of exosomes, ensuring their safety, efficacy, and consistency. Sourced from well-characterized biological materials, such as human umbilical cord blood and adipose tissue, our exosomes undergo rigorous purification and quality control processes. Using advanced technologies like nanoparticle tracking analysis and electron microscopy, we verify their size, concentration, and biological activity. Our ongoing research is dedicated to exploring the therapeutic potential of exosomes in regenerative medicine, focusing on applications in immune modulation, tissue repair, and treatment of conditions such as neurological, cardiovascular, and musculoskeletal diseases. With a commitment to advancing exosome therapies, BHI is at the forefront of providing innovative, effective, and minimally invasive treatment options.

BHI Stem Cells Regulatory Compliance

At BHI, we are fully committed to maintaining the highest standards of regulatory compliance in the production and use of exosomes for therapeutic applications. Our exosome therapies adhere to stringent regulations set by global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). We ensure that all processes, from sourcing biological materials to exosome isolation, purification, and storage, meet or exceed industry standards for safety, quality, and traceability. Our facilities are certified for Good Manufacturing Practices (GMP), ensuring that every step of the production process maintains the highest quality and safety benchmarks. Additionally, our exosomes are subject to thorough testing to confirm their purity, potency, and lack of contaminants, ensuring they are safe for clinical use.

We also ensure that all research and clinical applications of exosome-based therapies are conducted in full compliance with ethical guidelines and regulatory frameworks. Our team works closely with regulatory bodies to ensure that our exosome products meet the necessary requirements for clinical trials, patient safety, and post-market surveillance. This includes adhering to the latest guidelines for cell-based and gene therapies, ensuring that our products are both effective and safe for patients. BHI’s dedication to regulatory compliance allows us to provide innovative exosome therapies while maintaining transparency, ethical practices, and patient trust, all while advancing the field of regenerative medicine in a responsible and sustainable manner.

Exosomes