Dr. Michael Heke, Ph.D. will drive integration of exosome-based topical cosmetics, regenerative biotherapeutics medical and scientific intelligence, and as well as aspects of patient safety as Managing Director-Scientific Officer.
Rochester, NY, February 8, 2023 — The Crowley Center™ for Regenerative & Biotherapeutics, LLC (aka AT Venture Center™, LLC) today announced that Dr. Heke has been appointed as Chief Scientific Officer of The Crowley Center, and its subsidiaries, Regenerelle™ Cellular & Exosome Biotherapeutics, Resiliélle™ Exosome Cosmetics, Sanatela® Regenerative Medical, Sanatela® AT Medical Solutions, Sanatela® Precision Cancer Diagnostics, Sanatela® Animal Biotechnologies, Sanatela® Biotechnologies, Sanatela® Matrix, Sanatela® Life Sciences and AT Venture Center for Global Techtrepreneurship™. Regenerelle’s and Sanatela’s IP technologies are both Patent Pending.
The Crowley Center is a private, family owned, U.S.-based regenerative biotherapeutics and cosmetics investment and advanced technology commercialization company focusing upon the development of Umbilical Cord Wharton’s Jelly-derived allogenic off-the-shelf stem cell and exosome therapies and biomaterial-based regenerative therapeutics products,
“The Crowley Center’s unique investment and commercialization strategy leverages a diversified portfolio of regenerative medical and biotherapeutic technologies all derived from a single donated source material — the ethically sourced post-partum Wharton’s Jelly derived from umbilical cords of healthy births. As one of America’s leading venture building firms, our Company has pioneered the use of off-the-shelf Wharton’s Jelly-derived stem cells and exosomes, and as one of the world’s leading manufacturing innovators in Wharton’s Jelly biomaterial product development, The Crowley Center’s business model is to generate commercial revenue from both cellular and regenerative biotherapeutics, including technologies that combine cellular, exosome and regenerative biotherapeutics.
This appointment adds to Dr. Heke’s prior advisory role responsibilities aligning and integrating the company’s scientific, medical, clinical research and regulatory affairs under his advisory committee leadership. It leverages his deep expertise and understanding of the interaction between patients, and the clinical translation of innovative research, such as the implementation of biotherapeutics and regenerative medical technologies to accelerate such innovation with an emphasis on putting patients and our cosmetics-customers first.
“With this appointment, we’re enabling a patient-centered approach to regenerative medical and biotherapeutics healthcare and topical exosome cosmetics technology innovation at every stage of the product lifecycle,” said Professor Michael Crowley, J.D., Co-founder, Chairman, Co-Managing Member and CEO, The Crowley Center™.
Erin Crowley Ellis, BS ME, a graduate of the Rochester Institute of Technology (RIT) and a Quality Manufacturing Expert, Co-Founder, Co-Managing Member of The Crowley Center and its subsidiaries and CEO of Resiliélle /rəˈzilēélle/ Cosmetics, said “Dr. Heke’s expertise and leadership connects industry leading product quality and scientific intelligence with the rapid advances in regenerative medicine and biotherapeutics using Umbilical Cord Wharton’s Jelly tissue and its derivatives to manufacture and distribute our many industry leading products. Mike has carefully, professionally and skillfully advised our start-up and early-stage investments, its venture building firm and its advanced technology subsidiaries during both the critical launch, scaling, and rapid growth period of Regenerelle’s Mesenchymal Stromal (Stem) Cells (MSCs) and Extracellular Vesicles known as Exosomes, Resiliélle’s Exosome Cosmetics, Sanatela’s Wharton’s Jelly (WJ) Extracellular Matrix for Wound and Burn care, Sanatela’s WJ-Matrix used for Precision Cancer Cell Treatment Evaluation, Sanatela’s Wound Care Matrix, Bandages and (WJ) Stem Cells used for Veterinary Practice, and ensuring we have a clear appraisal of the medical and scientific landscape as we make investment decisions, and helping to deliver effective and reliable innovations for patients and healthcare providers.”
Mike has a PhD in Biology and started his career in pharmaceutical research in industry (Bayer AG) with an emphasis on cardiovascular research. In 2001, he shifted his interests towards stem cell research and its translational potential, and later co-led clinical trials for stem cell therapy in heart failure at Düsseldorf’s University Medical School. During his tenure as Head of Department of Knowledge Management at the Institute of Neurophysiology, University of Cologne, he was appointed as the Scientific Coordinator of the large-scale collaborative EU-Projects ESNATS and DETECTIVE, and served as SEB member of the SEURAT-1 integrated research cluster.
He was secretary to the German Society for Stem Cell Research (GSZ), and co-initiated the German Stem Cell Network (GSCN), being appointed by the German Federal Ministry for Education and Research (BMBF). In 2013, he returned to The Rockefeller University, New York, where he assumed a position as Deputy Head of the Laboratory of Stem Cell Biology & Molecular Embryology. In 2016, he joined the President’s laboratory at Stanford University as a Senior Research Scientist and managed the Bing Presidential Laboratory in Stanford’s Department of Biology.
Dr. Heke will also lead the continued acquisition of new worldwide exclusive technology license from leading universities and government research centers, new product development and integration of robust and independent regenerative medical and cellular therapeutics expertise into the company’s business processes, including investment decisions, business development, exploration of new biotherapeutic areas and development of novel regenerative medical technologies.
“The Crowley Center is fortunate to have world-leading advisors and experts across diverse scientific and medical fields who provide unique insights and breakthrough discoveries. I’m excited to integrate this expertise across our company, to connect technology innovation with better health outcomes for patients and Resiliélle’s new launch of its topical exosome-based cosmetics product for skin renewal and hair regrowth designed for MedSpas, Dermatologists and Plastic Surgeons,” said Dr. Heke. “A strong scientific, cosmetics-customer and patient-centered mindset across all stages of manufacturing and new product development will enable innovation in the application of cosmeceuticals all the way to groundbreaking translational medicine later saving and improving lives, but also addresses the need for skin regeneration/rejuvenation or hair regrowth hair when used with adjunct therapies such as microneedling, laser treatments, or other related skin and scalp treatments.”
Dr. Heke joined The Crowley Center three years ago when he initially became a member of the company’s Sanatela Matrix Advisory Committee. In his time with the company, he has provided innovative leadership to not only Sanatela’s wound care clinical trial design with Cornell University and data science, he also created new evidence pathways, provided critical regenerative allogeneic stem cell and exosome medical and scientific input to investment decisions, delivered leadership to patient safety, and helped the company’s sponsored regulatory advances and participation in multiple international IRB-approved clinical studies that have the potential to positively impact patients worldwide. Mike has also advised Regenerelle as it launched its clean room laboratory on January 1st, 2021, that is currently the world’s leading manufacturer and distributor of WJ-MSCs, and Exosomes derived from WJ-MSC growth media.
About The Crowley Center
Advanced technology education, research and development investment, venture building, commercialization is our business. We are also known as AT Venture Center, LLC and Sanatela Medical Solutions are headquartered Rochester, NY. Our laboratory manufacturing facilities and NY State Tissue Bank for both Regenerelle, and Sanatela® Biotechnologies are in located in Fairport, NY. Resiliélle Cosmetics is headquartered in Ft. Lauderdale, FL. We are a leading global manufacturing and sales regenerative medical and biotherapeutics healthcare and topical cosmetics technology company that fearlessly attacks the most challenging health and topical skin care problems facing humanity by searching out and finding solutions.
The Crowley Center’s mission is to treat serious or life-threating injuries, illnesses and conditions by using biotherapeutics, alleviate pain via exosome treatments, regenerate tissue, regrow bone, treat degenerative diseases, overall health, and extend both human and animal life — unites our highly dedicated and creative team of passionate people currently working across 10 countries. Our technologies and therapies are being used in multiple clinical trials conducted in regenerative medical clinics outside the US to treat many serious or life-threatening health conditions and include an IRB-approved patient-funded clinical study on the effects of cord tissue-derived MSCs on the treatment of chronic low grade inflammation (which is part of the overall aging process,) and the treatment of animal wounds and burns, traumatic brain Injury (TBI), cardio vascular disease, spinal cord injury, musculoskeletal disorders, stroke, dementia, Alzheimer’s, multiple sclerosis (MS), Parkinson’s disease. Crohn’s disease, ALS, and many other orthopedic and degenerative medical conditions.
Energized by our diverse knowledge of regenerative medicine and cellular biotherapeutics, never ending curiosity, and an insatiable desire to help all those who need it with the highest quality products at a reasonable and affordable cost, we will continue to deliver innovative technologies that can more quickly heal animal and human wounds and burns without scaring, help isolate, culture, target and kill cancer stem cells using personalized precision treatment evaluation, revitalize and beautify skin, regrow hair and transform the lives of patients and our cosmetics-customers every second, every hour, every day. We fully intend to continue to empower world class, highest quality and potency regenerative medical and biotherapeutics professional medical and topical cosmetics skin care, making our world a much better and healthier place to live.
About Regenerelle, LLC
Regenerelle, LLC, was founded in 2020 with a desire to create an entirely new IP production methodology (Patent Pending) to produce very large sale yields from each umbilical cord used to produce stem cells and exosome, and to advance the overall state of regenerative medicine, biotherapeutics and topical exosome-based cosmetics products by significantly reducing the cost of these products. Our initial goal was to make regenerative medicine affordable for everyone. We have met this goal!
Within a year of its inception, Regenerelle designed and started operations in an ISO Class 7 compliant clean room facility, conceptualized and launched a suite of Wharton’s Jelly products, developed an extensive product pipeline across a range of clinical applications, and established a portfolio of intellectual property. Regenerelle portfolio of products includes, WJ-MSCs, EVs and Exosomes derived from WJ-MSCs growth media.
We are currently the world’s leading producer and distributor of clinical grade WJ-MSCs and WJ-Exosomes for both regenerative medical biotherapeutics, as well as clinical and topical exosome-based cosmetic purposes. Regenerelle’s yield per low pass expansion of each umbilical cord is at approximately 7 – 10 billion WJ-MSCs and 250 trillion Exosomes obtained from each cord’s WJ-MSC growth media. To date, Regenerelle’s manufacturing capacity exceeds 20 billion WJ-MSCs and 750 trillion WJ-Exosomes per month. In March 2023, our clean lab will be expanded, allowing us to triple our current monthly production capacity. Each month Regenerelle sells over 15 billion WJ-MSCs internationally and sold trillions of WJ-Exosomes. Our cyrostorage tissue bank currently has over 3,000 quintillion WJ-Exosome stored at minus -190 degrees Celsius.
These groundbreaking products apply to a wide range of clinical applications and provide a foundation on which Regenerelle™ is developing new regenerative technologies and biotherapeutics at the intersection of biotherapy, cellular therapy, topical exosome cosmetics treatments and human cell and tissue applications.
About Sanatela® Regenerative Medical and Sanatela Animal Biotechnologies
In July,2022, Sanatela successfully completed its large animal pre-clinical trial in cooperation with Cornell University demonstrating the safety and efficacy of the use of our Sanatela Matrix that is a sturdy gauze-like material made of 100% Decellularized Wharton’s Jelly Matrix (DWJM) umbilical cord tissue. The Sanatela Matrix is microbioengineered-approved to take advantage of the fact that stem cells “home” to Wharton’s Jelly tissue. The interior of the Matrix resembles the internal structure of bone marrow that naturally also attracts stem cells to home into our gauze-like extracellular matrix which alleviates the typical formation of scar tissue that normally serves as natures extracellular matrix.
The Matrix’ 3D structure provides an ideal scaffolding for accelerated tissue growth. The Matrix’ is immune-privileged, and has been clinically proven to promote the recruitment, infiltration, and differentiation of stem cells. The Matrix not only accelerates skin repair in both small and large dermal wounds and burns, but it also forms a protective base layer over difficult-to-heal wound and eliminates regular wound dressing changes since the Matrix is absorbed into the skin to reduce scarring and surgical complications.
Sanatela Biotechnologies has leased and fully equipped a Matrix manufacturing lab in Fairport, NY that will be able to produce substantial amounts of dressing that has been homogenized, lyophilized and terminally sterilized for the treatment of animal wounds and burns for veterinary purposes. Sanatela initially intends to market and sell the Sanatela Matrix for veterinary purposes, however, we intend to use the results of our pre-clinical trials with large animals to support an application to the FDA to seek its approval to use our matrix for human wounds, burns and especially for diabetic foot ulcers. The Matrix can be easily and rapidly cut to match the size of the wound, secured with sutures, adhesives, bandages, or molded or shaped to penetrate cavities.
About Sanatela Matrix for Precision Cancer Treatment Evaluation
The Matrix is currently being evaluated as a platform to screen cancer treatments, starting with leukemia. Its 3-dimensional microenvironment that imitates the bone marrow “niche,” enables and regulates the ability of Hematopoietic Stem and Progenitor Cells (HSPCs) to renew themselves. This novel in vitro culture system is based on Decellurized Wharton Jelly Matrix (DWJM) isolated and processed to form an extracellular matrix (ECM) scaffold and manufactured by Sanatela Biotechnologies at its Matrix manufacturing lab in Fairport, NY. Researchers can then validate chemotherapies and other cancer treatments and test their effectiveness in isolating, targeting and killing cancer stem cells in a bone marrow-like environment. Sanatela will develop the Matrix to support ongoing university-based cancer center research and intends to use it for clinical trials for multiple types of cancers.
Leukemia stem cells are thought to support leukemia survival. They are an intense focus of research, but to study them researchers must recreate the environment in which they live and function – the bone marrow (BM) hematopoietic “niche”. This niche also supports the HSPCs that are formed soon after conception, starting out in the yolk sac and eventually moving to the bone marrow of mammals, where it provides the protection and signals necessary to carry out the differentiation of normal blood cells.
The Matrix also provides structural and biochemical support to expand HSPCs like Umbilical Cord Blood (UCB) CD34+ cells, which are attracted to the Matrix.
About Resiliélle Exosome Cosmetics
RESILIÉLLE’s vision started with the idea of developing the first ever cosmetic exosome product so powerful it activates skin stem cells to take a “Leap Back in Time™.” Exosomes have routinely been described as an exciting new antiaging ingredient used for skin rejuvenation. Exosomes are a safe way to entice cells to have a specific action because they demonstrate very low immunogenicity. This means that the same antiaging skin effects can be achieved without having to use actual stem cells. Beauty and hair regrowth treatments using Resiliélle’ topical exosome cosmetics have already found stateside success for its impressive calming, soothing, brightening and hair regrowth benefits.
Our exosomes are nano-sized vesicles secreted from different cell types that contains any of various active biomolecules, such as proteins, RNAs, DNAs, lipids or miRNAs. Exosomes are defined as small vesicles ranging from 30-100nm in size that are found in nearly all eukaryotic fluids and facilitate a range of important cellular functions. They transfer DNA, RNA, growth factors and proteins or nucleic acid to other cells, thereby altering the function of the target cells. Exosomes are lipid membrane packets that contain cell signaling molecules that allow cells to communicate with each other. These molecules regulate exosomal intercellular communication and target specific cell types. The delivery of these molecules may also alter the cell function.
What are Exosomes?
Exosomes are produced in extremely abundant amounts. Exosomes are enveloped in a lipid bilayer membrane, reflecting their origination from endocytic (intracellular) compartments; they range from 30–150 nm in diameter. Exosomes are secreted via exocytosis by a variety of cell types, and subsequently are taken up by target cells, where they communicate information via surface protein signaling as well as through the transfer of lipids, nucleic acids, and other biomolecules. Intercellular communication by exosomes plays a critical role in the regulation of cellular and physiological processes. Exosomes interact with the recipient cells via surface receptor molecules and ligands. When the surface receptors bind the exosome, internalization of the exosome occurs by endocytosis. This allows cells to transfer RNA material and proteins from one cell to another.
Exosomes were first described in the early 1980s, when they were observed following their secretion by reticulocytes. Exosomes are continually secreted by cells, with their release typically modulated by factors such as cellular stress and cell signaling. Once secreted, exosomes may be taken up by adjacent cells or may travel to distant cells; in some instances, exosomes act on the cells from which they were secreted.
Exosomes communicate a wide range of information to target cells, depending on the cell types from which they originate and depending on the cell surface proteins and biomolecules they carry. In particular, exosomes perform important activities that influence immune responses, cell proliferation, and neuronal signaling. Exosomes released from lymphocytes and macrophages, for example, express proteins of the major histocompatibility complex, which serves a critical role in antigen presentation and T-cell activation during immune responses. Exosomes are also thought to influence RNA expression and function in target cells, because of the transfer of biomolecules that are capable of actively modulating RNA targets.
There are significant variations in the source, isolation methods, size and contents of exosomes. Therefore it is important to understand that not all exosomes function the same way. This is where we are beginning to see the problem in cosmeceutical claims cropping up. Just because a product has exosomes in it does not mean it has been proven to work. Make sure you know the source of the exosomes and the data behind the product before you get excited about one of these exosome-containing skin care products.
Exosomes are of special interest in the field of cosmetics and medicine. Their ability to stimulate immune responses, for instance, has made them of particular interest in the development of novel approaches to microneedling and laser treatments including the development of new exosome cosmetics to apply topically to skin. Exosome therapy has been called the Dermatologists’ new favorite skin-rejuvenation and hair regrowth treatment.
When exosomes derived from Wharton’s Jelly mesenchymal stem cells growth media were placed on skin that had been microneedled, or had a laser treatment, this procedure has led to an overall improvement in the skin’s appearance. The injury caused by microneedling or laser treatment creates an inflammatory trigger that stimulates the exosomes to respond with regenerating signals. Multiple studies have clearly shown that when the correct type of exosomes, like Resiliélle Wharton’s Jelly derived exosome type, are placed on the skin after microneedling, rejuvenation is seen.
How do exosomes work?
Board-certified dermatologist Ramya Garlapati, MD, tells Allure. “They work by communicating and transmitting signals between cells. You can think of them as messengers sending signals to unhealthy cells, triggering them to regenerate. Eunice Park, MD, dual board-certified facial plastic and reconstructive surgeon in Syosset, New York tells Allure. ” In other words, exosomes prompt the body’s natural healing process,” Following exosome cosmetic treatment, multiple studies have demonstrated statistically significant improvement in skin health noted by decreased redness and improvement in wrinkles. It was safe and well tolerated.
It is certain that the source, quality, and quantity of exosomes has a significant impact on the outcome. For this reason, we provide product details and certifications on the types of exosomes we are using in our topical cosmetic antiaging products.
Exosome therapy involves the application of topical exosomes (in the form of what looks and feels like a saline solution, serum or gel) after treatments like resurfacing lasers or microneedling. Allure author Devon Ableman calls exosome therapy as the cherry on top of in-office treatments because it can only be done in conjunction with one — never on its own.
Dr. Marina Peredo, M.D. a New York City board-certified dermatologist told Allure that exosomes are used in with microneedling or laser treatments because, “Although exosomes are nanoparticles, they cannot penetrate skin on their own. They need those disruptions in the superficial layer of skin to start communicating with skin cells. Otherwise, they’d just sit on the surface of your skin doing nothing.” (This is also the reason why over-the-counter serums and creams aren’t spiked with exosomes just yet.)
Our team of scientists strategically designed RESILIÉLLE’s exosome-based cosmetics products to be derived from human Umbilical Cord Wharton’s Jelly Mesenchymal Stem Cell (WJ-MSC-EXO), which have a natural power to harnesses Age-Zero nanotechnology.
Dr. Garlapati, told Allure that since exosome are continually active over a period of six to eight months post-treatment, the results will last longer than Botox. You can also get them as often as you get your laser or microneedling treatments done.
A truly unique feature of our proprietary exosome-based cosmetics product is that it remains completely stable – with just normal refrigeration – for up to 120 days! Other exosome products, currently in the marketplace, either must be shipped (freeze-dried) “lyophilized” and then rehydrated by the user or shipped Cyro-frozen to be used immediately (or within a few days) in a saline solution after being unfrozen.
Why did RESILIÉLLE chose WJ-MSC-Exosomes?
After reviewing numerous clinical research publications, the global exosome community unanimously concluded that WJ-MSC-EXOs are in fact, the most potent exosomes among all exosome types.
On a mission to produce the best-in-class exosomes, RESILIÉLLE partnered up with the leading Wharton’s Jelly Mesenchymal Stem Cell manufacturing firm Regenerelle LLC. RESILIÉLLE then conducted R&D with our extensive network of scientific and medical collaborators with numerous years of collective experience in skincare to make certain we provide our customers with the Gold Standard of exosomes.
For more information on The Crowley Center and its subsidiaries please visit:
Source: Crowley Center for Regenerative & Biotherapeutics