The filing of an IND application is the first step in a long, complicated process aimed ultimately at approval of a new therapy. A clinical hold is an order issued by the FDA to a sponsor to delay a proposed trial to obtain more data. California Stem Cell is actively working on collecting the new data requested by the FDA. Please click here for more on the clinical trial process.
Past Program Milestones: -The Kerr lab publishes studies showing motor neurons from mouse embryonic stem cells provided therapeutic benefit in a rodents. Please click here for the paper. -Production of motor neurons from human embryonic stem cells are published (See Figure 1). The product is called MotorGraft. Please click here for the paper.
Figure 1. Human motor neurons produced at greater than 95% purity.
More Information on the history of program can be found in the link above.
Families of SMA understands that the use of stem cells is a controversial subject. As an organization, FSMA is committed to pursuing the most promising treatment possibilities. However, we also understand that ethical and religious issues remove stem cells as an option for some of our families and donors. For that reason, any donor to FSMA may restrict their donation to non-stem-cell-related research. To do this simply indicate - not for stem cell research - when you make your donation.