SBIR-STTR Award

Bone marrow derived stem cells are a non-controversial, attractive source of adult stem cells that can advance the study of stem cell biology, stem cell based therapies, and regenerative medicine. Approximately 60,000 patients are treated with bone marrow transplantation (BMT) per year worldwide. Since the early 1970's, BMT has been a treatment cornerstone for a variety of diseases and disorders. Historically, BMT has primarily been utilized in the treatment of malignancies. Now, there is increasing research and use of BMT in the treatment of non-malignant genetic and autoimmune diseases. Because bone marrow contains mesenchymal stem cells, in addition to hematopoietic stem cells and progenitors, and other cell populations that may prove important to tissue regeneration, additional uses of bone marrow derived stem cells are rapidly evolving for the repair of a wide variety of tissues. As stem cell biology matures, it is anticipated that marrow derived stem cells will play a role in the treatment of a diverse array of disorders, including cardiovascular disease and those of the liver, kidney, and pancreas. Acquiring bone marrow stem cells however is, traumatic, difficult, time consuming, and expensive when utilizing current invasive operative techniques, which have gone essentially unchanged for over 40 years. To obtain 1 or more liters of marrow for BMT, about 100 to 300 separate trocar entries and small-volume aspirations are taken from the donor's posterior ileac crest. The operation is performed under general anesthesia, and requires two transplant physicians, a full operating room team, and costs over $15k/harvest. Consequently, hematopoetic stem cells are increasingly being obtained from mobilized peripheral blood; despite, (1) an increased incidence of life threatening graft versus host disease (GVHD) in the allogeneic transplants, and (2) unknown long term risks to the donor from prolonged (at least 5 days of injections) dosage with granulocyte colony stimulation factor, which is needed in order to stimulate bone marrow stem cell production. Because of drug costs and the length of aphaeresis sessions needed in order to obtain an adequate number of CD34+ cells, each donor collection costs about $15k. From a clinical perspective, mobilized PBSC stem and progenitor cells populations are not as diverse as cells obtained from marrow, and contain a higher fraction of T-cells, contributing to increased GVHD. Given the current and future therapeutic uses for adult, marrow derived cells, improved methods for harvesting bone marrow are needed. StemCor Systems is developing a minimally invasive bone marrow harvesting device that is designed to rapidly harvest significant volumes of bone marrow through a single entry into the iliac bone within an outpatient setting under local anesthesia. Proof-of-concept development has been completed utilizing basic and large scale prototypes. In Phase 1, advanced, integrated prototypes will be designed, fabricated and tested on bench top models and in live animal models to demonstrate bone marrow harvesting feasibility. Relevance: By making access to adult stem cells faster, less expensive, and more convenient, the minimally invasive bone marrow harvesting device being developed by StemCor Systems will enable improved clinical care and outcomes for bone marrow transplant patients and their marrow donors, facilitate advances in stem cell biology, and support advances in regenerative therapies, which utilize stem cells harvested from the patient to repair the patient's own damaged tissue. This device will facilitate bone marrow stem cell derived treatments for a wide variety of diseases and disorders, including cancer, genetic disorders, and autoimmune diseases.

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Regenerative medicine, particularly using autologous adult stem cells, is a rapidly expanding and maturing field with the promise to address diseases in multiple organ systems. Marrow derived stem cells are already in extensive clinical and commercial use in bone marrow transplantation and the orthopedic space. But the clinical potential for regenerative therapies in several huge clinical areas -- CHF, myocardial infarction, and especially critical limb ischemia -- is poised to take off, with unusually compelling clinical data and a growing tailwind. Other expansive markets -- diabetes, stroke and many other major disease states - have promising early findings. There are literally hundreds of planned and ongoing clinical trials involving bone marrow derived stem cells. Many clinical indications, and present and future trials will require a rich and reliable source of the patients own marrow-derived stem and progenitor cells. RegenMed's Place in the System: Every regenerative medicine product system requires a triad of stem cell collection/harvesting, separation, and delivery. Most of the research and investment dollars to date have been spent on stem cell separation and especially delivery. In that light, our Marrow Harvesting System swims upstream from others in this exciting space. This presents immense opportunity for collaboration and joint commercialization with many trials. We have been approached often for this purpose in recent months. Our Product-Past, Present, and Future: Unfortunately, the current 40-year-old harvesting technique (utilizing serial small volume needle extractions) is painful, low-volume, and often requires general anesthesia. RegenMed Systems owns an exclusive license from Stanford University for the core patents around a novel marrow harvesting system designed to obtain significant volumes of rich bone marrow in a minimally invasive manner (one stick under local anesthesia), by using a powered flexible shaft specifically designed to move through the confines of the pelvis. Our core team (Daniel Kraft, Vartan Ghazarossian, and Mike Crocker) obtained a Phase-I SBIR in 2008 with a score of 139. Our core team met and exceeded all our stated objectives, eventually obtaining a 510k and CE mark and bringing the technology into human trials where it showed superior marrow harvesting with surprisingly robust stem-cell yield. We have added two new exciting team members/leaders with deep experience in developing and commercializing medical devices. RegenMed Systems seeks a Phase-II SBIR to build the next generation product. Specifically, we want to improve the handle (function and features) and improve the flexible shaft. We want to apply lessons learned from the Phase-I, Generation-I device, to bring our marrow harvesting system to scale and into incorporation as the harvesting component of multiple organ-specific clinical trials and regenerative medicine systems (either our own or in cooperation with other stem cell delivery companies) treating tens of millions of patients annually. See TED Video: ://www.ted.com/talks/daniel_kraft_invents_a_better_way_to_harvest_bone_marrow.html

Public Health Relevance:
The Phase-II SBIR will allow RegenMed Systems to perfect a marrow harvesting system that will revolutionize the way pelvic bone marrow is collected. Less pain. Less Anesthesia. Instead of dozens, more life-giving cells with one stick. This is particularly important as pelvic marrow is the biggest and richest source of adult stem cells and progenitor cells in the body. Hundreds of new studies suggest that these special marrow derived cells can potentially re-energize a number of organs, offering new hope to low-hope or no-hope diseases such as advanced CHF (congestive heart failure) or critical limb ischemia - with new treatments for diabetes, heart attack, bone healing, and even stroke potentially around the corner. The commercial version of our Generation-II Marrow Harvesting System, with the improved handle and flexshaft, will allow us to energize the entire field of autologous (using your own cells) stem-cell research as we synergistically provide better marrow for leading clinical studies.

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