About Exosomes
Our manufacturer has spent the last 10 years researching the most safe and efficacious way to bring regenerative medicine to the market while abiding by Federal regulatory policy. Since that time, they have pursued research into the stem cell field and refined their understanding of the mechanisms at play and evolved their approach to best meet the regulatory standards that have been developed. They have established strategic partnerships with an accredited SEC university health foundation and a former senior investigator for the FDA’s Center for Biologics Evaluation and Research (the authority on regenerative medicine regulation). Through guidance and research, they learned that the most efficacious and safe method of treating people with a wound or injury is using umbilical cord derived mesenchymal stem cell exosomes. They have worked tirelessly since this time self funding their research and working with local medical facilities for placental material used in their research in order to be the frontrunner in the industry and soon become the first fully legal, FDA approved human umbilical cord mesenchymal stem cell derived exosome product on the market.
Safety & Compliance
Registered as a 351(a) biological drug with an FDA Master File, our exosomes adhere to FDA regulatory standards, ensuring the highest level of safety and compliance in the industry. This commitment to regulatory adherence guarantees a safe and effective product.
Therapeutic Efficacy
Demonstrating high efficacy in wound healing, bone regeneration, and anti-inflammatory effects, our exosomes offer a broad spectrum of therapeutic applications, enhancing patient care and outcomes. Their proven effectiveness makes them a valuable tool in the arsenal of regenerative medicine, transforming patient recovery and healing processes.
Quality Assurance
Manufactured in ISO-5 clean rooms, our exosomes undergo third-party testing to verify component concentrations, with each batch receiving a Certificate of Analysis (CoA) for guaranteed quality. This rigorous quality control ensures that every batch meets the highest standards, delivering consistent and reliable results for medical professionals.
High Potency
Our exosomes boast an exceptional concentration of 20 billion per 1ml solution, offering superior potency compared to standard market offerings. This high concentration means more effective treatment outcomes and reduced need for frequent applications, making it a cost-effective solution.
Convenience
Our exosomes can be conveniently stored in a standard freezer for up to six weeks, or in a cryo-freezer for as long as 18 weeks, without losing their potency. Additionally, they can be re-frozen up to three times, offering unparalleled flexibility and longevity in use.
Ethical Practices
Extracted from mesenchymal stem cells in human umbilical cords from extensively screened, healthy donors, our exosomes boast exceptional quality and regenerative potential. Meticulous safety protocols and ethical sourcing practices ensure the highest standards of product integrity and efficacy, reflecting our commitment to excellence in regenerative medicine.
Market Leadership
As a leading distributor in the field, MedReps collaborates with an FDA Master File certified laboratory, setting a benchmark in the industry. Our leadership reflects a commitment to innovation and quality, ensuring top-tier regenerative products for our clients.
Non-Lyophilized
Unlike many competitors' lyophilized exosomes, our non-lyophilized exosomes maintain a higher level of biological activity and stability. This ensures greater efficacy in therapeutic applications, providing a more potent and effective solution for regenerative treatments.
Frequently Asked Questions
What are MSC Exosomes?
Mesenchymal stem cell exosomes are at the forefront of healing innovation, offering a glimpse into the future of regenerative medicine. They operate on a simple yet profound principle: When tissue is injured, it emits signals that are picked up by stem cells. These stem cells then craft specialized healing components and package them into exosomes. Like precise, targeted delivery vehicles, these exosomes travel to the injured site, attach themselves, and release their therapeutic payload directly to the damaged tissue. This process initiates a remarkable healing response, aiding in tissue repair, reducing inflammation, and rejuvenating affected areas. Research has shown the remarkable efficacy of stem cell-derived exosomes in a variety of applications, from repairing nerve damage and accelerating wound healing to regenerating skin and bone. While the full potential of exosomes is still being explored, with no FDA-approved products yet, the promise they hold in transforming regenerative medicine is undeniable and truly exciting.
How do MSC Exosomes Work?
Why use Umbilical Cord Exosomes?
Mesencyhmal stem cell exosomes represent a groundbreaking shift in regenerative medicine, offering a powerful, low-risk alternative to traditional stem cell therapies. With stringent regulations surrounding live stem cell usage, umbilical cord exosomes emerge as a safer and more versatile solution. Unlike tissue transplants that are limited in application, or self-derived stem cells that diminish in effectiveness over time, our approach harnesses the vitality of newborn-derived mesenchymal stem cells. These cells, sourced from the umbilical cord, are at their peak of potency and regenerative capability. In our state-of-the-art labs, we meticulously screen, culture, and nurture these cells, ensuring the highest standards of safety and efficacy. This process results in the production of exosomes rich in regenerative factors, consistent in quality, and unparalleled in their healing potential. Each batch of these exosomes undergoes thorough testing before being released for research, setting a new benchmark in the pursuit of advanced, effective medical treatments.
Mesenchymal stem cell exosomes are at the cutting edge of regenerative medicine, harnessing the healing power of cell-free exosomes to provide a safe and effective alternative to traditional live cell therapies. With the regenerative medicine industry facing intense scrutiny and misinformation, the FDA has stepped in to ensure that all such products undergo their rigorous regulatory process. Our manufacturer is leading the charge in compliance. They have meticulously registered a biologic Drug Master File with the FDA for their exosomes, a pioneering move in the industry. This Drug Master File is a critical step in the journey towards FDA approval, showcasing an unwavering commitment to manufacturing and scaling a clean, efficacious, and safe product every time. Their dedication to this process reinforces a position as a trusted and responsible leader in regenerative medicine, ready to meet the needs of tomorrow's healthcare, today