San Diego Regenerative Medicine Institute

San Diego Regenerative Medicine Institute (SDRMI), a nonprofit independent biomedical research institute incorporated in California with 501C3 IRS tax-exempt status, was founded in 2010 to facilitate the transition of human stem cell research towards stem cell therapy to provide the next generation of cell-based therapeutic solutions for unmet medical challenges in world-wide major health problems. SDRMI is committed to the leading position in pluripotent human embryonic stem cell (hESC) research & cell-based regenerative medicine by developing groundbreaking hESC technology platforms and innovative cell-based regenerative medicine approaches.

Given the limited capacity of the central nervous system (CNS) and the heart for self-repair, cell-based therapy represents a promising therapeutic approach to restore the damaged or lost tissue and function. However, to date, the existing markets lack a clinically-suitable human neuronal cell source with adequate CNS regenerative potential, which has been the major setback in developing safe and effective cell-based therapies for regenerating the damaged or lost CNS structure and circuitry in a wide range of neurological disorders. Similarly, to date, the existing markets lack a clinically-suitable human cardiomyocyte (contractile heart muscle cell) source with adequate myocardium (the contractile heart muscle) regenerative potential, which has been the major setback in developing safe and effective cell-based therapies for cardiac repair in heart disease and failure.

 

The human embryonic stem cells (hESCs) are derived from the pluripotent inner cell mass or epiblast of the human blastocyst. The intrinsic ability of a pluripotent hESC for both unlimited self-renewal and unrestricted differentiation into clinically-relevant lineages makes it a practically inexhaustible source of replacement cells for human tissue and function restoration. Therefore, it has been regarded as an ideal source to provide a large supply of functional human cells to heal the damaged or lost tissues that have naturally limited capacity for renewal, such as the human heart and brain. 

Due to the prevalence of the CNS and heart diseases worldwide, there is a large unmet healthcare need to develop hESC-based therapeutic solutions to provide optimal regeneration and reconstruction treatment options. We have established ground-breaking proprietary human stem cell technology platforms (PluriXcel Technology), including defined culture systems for derivation and maintenance of clinical-grade high quality hESC lines (PluriXcel-DCS) and lineage-specific differentiation of pluripotent hESCs by small molecule induction (PluriXcel-SMI). Our PluriXcel technology platforms enable large scale production or manufacture of high quality clinical-grade human neuronal and heart muscle cell therapy products as cellular medicines that can offer pharmacologic utility and capacity adequate for CNS and heart regeneration in unmet medical challenges. Breakthroughs of our PluriXcel technologies transform non-functional pluripotent hESCs into a large commercial scale of high quality fate-restricted functional cell therapy derivatives or products (Xcel prototypes) for commercial and therapeutic uses, marking a turning point in cell-based regenerative medicine from current studies in animals towards human trials or first-in-human studies. Our cutting-edge human stem cell technology and medical innovations enable high efficient direct conversion of pluripotent hESCs by small molecule induction into a large scale of clinical-grade high quality human neural or cardiac lineage-specific cell therapy derivatives, including our cell therapy product Xcel-hNuP (human neuronal progenitors), Xcel-hNu (human neurons), Xcel-hCardP (human heart precursors), Xcel-hCM (human heart muscle cells), which is a major milestone towards human trials of hESC cell therapy derivatives, offering the benefits in efficiency, stability, safety, efficacy, and large-scale production of high quality human cell therapy products in cGMP facility for commercial and therapeutic uses over all other existing approaches. Currently, our proprietary Xcel prototypes of human neuronal and cardiomyocyte cell therapy products, including Xcel-hNuP (human neuronal progenitors), Xcel-hNu (human neurons), Xcel-hCardP (human heart precursors), Xcel-hCM (human heart muscle cells), are the only available high quality human cell sources in commercial scales with adequate cellular pharmacological utility and capacity to regenerate neurons and contractile heart muscles in the clinical setting, providing potential treatments or cures for unsolved major health problems in a wide range of neurological and cardiovascular diseases.