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. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43GM083392-01
Application #
7394902
Study Section
Special Emphasis Panel (ZRG1-SSMI-K (10))
Program Officer
Somers, Scott D
Project Start
2008-05-01
Project End
2008-10-31
Budget Start
2008-05-01
Budget End
2008-10-31
Support Year
1
Fiscal Year
2008
Total Cost
$115,516
Indirect Cost
Name
Stemcor Systems, Inc.
Department
Type
DUNS #
787329700
City
Menlo Park
State
CA
Country
United States
Zip Code
94025