NeoStem (now renamed Caladrius Biosciences)
In 2009, Enhance Cell Bank acquired NeoStem (now renamed Caladrius Biosciences; NASDAQ: CLBS) exclusive patent for stem cell application technology in China and Taiwan. Now Enhance acts as an investor of Caladrius Biosciences and continues to be in line with international standards.
Caladrius Biosciences is developing innovative products to treat cardiovascular and autoimmune diseases including four programs in mid to late stage development centered around two different proprietary technologies.
CD34 cell technology has led to the development of CLBS12, a product designed to stimulate the growth of microvasculature and address diseases and conditions caused by limb ischemia. Through the administration of CD34+ cells, Caladrius seeks to promote the development and formation of new micro blood vessels and thereby increase blood flow to the ischemic area. Caladrius currently has a pivotal Phase 2 trial investigating CLBS12 (a candidate for critical limb ischemia) underway in Japan. CLBS12 has received SAKIGAKE designation for expedited development and review and has been deemed eligible for consideration of early conditional approval by the Japanese regulatory authorities.
Caladrius’s CD34 cell technology also has potential to address multiple cardiovascular diseases. CLBS14 is Caladrius’s proprietary and patent-protected formulation of CD34+ cells designed specifically to repair and regenerate cardiovascular tissue. CLBS14-CMD is in the ongoing ESCaPE-CMD Phase 2 clinical trial in the USA for coronary microvascular dysfunction and CLBS14-RfA is in Phase 3 development for refractory angina in the USA.
CLBS03 is an autologous ex vivo polyclonal T regulatory cell ("Treg") clinical Phase 2 therapy targeting adolescents with recent-onset type 1 diabetes mellitus. This program evolved from our second technology platform involving the use of Tregs to treat diseases caused by imbalances in an individual's immune system. This novel approach seeks to restore immune balance by enhancing Treg number and function to treat and ultimately eliminate autoimmune diseases.
Through Caladrius’s technologies they leverage the potential of their cells by enabling the body to rebalance irregularities (T Regulatory Technology), and increase blood flow (CD34 Technology).
Heart attack, chronic heart failure, critical limb ischemia, and stroke are all caused by an acute or chronic deficit in the supply of oxygenated blood. One of the body’s natural responses to areas with low levels of oxygenated blood is the recruitment of CD34+ cells to those tissues. Caladrius’s CD34 technology leverages the body’s natural repair mechanism to induce the development of new blood vessels, preventing tissue death by improving blood flow.
T Regulatory Technology
Caladrius’s T regulatory cell program is based on a technology platform derived in part from intellectual property created from research performed at the University of California, San Francisco, and they are pursuing the development of cell therapies designed to use autologous cells as a therapeutic product to treat disorders of the immune system. Many immune-mediated diseases result from an imbalance between immune T-effector and T-regulatory cells whereby pro-inflammatory cells and cytokines eventually go unchecked and mistakenly attack beneficial cells in the body. Their T-regulatory cell therapy represents a novel approach to restoring immune balance by enhancing T-regulatory cell number and function to control pathologic immune responses.
Enhance Stem Cell Biology Technology signed a strategic cooperation agreement with Regenexx in 2018, and will establish China Regenexx Regenerative Medicine Orthopaedic Treatment Center in Enhance International Hainan Cell Medical Center to serve more patients suffering from degenerative orthopaedic diseases in the future.
Regenexx is a national organization of a group of American doctors specializing in musculoskeletal system specialists specializing in the most advanced regenerative medicine treatments developed by Regenexx. Its orthopaedic precision medicine has treated more than 68,000 patients worldwide.
Regenexx uses Interventional Pain Management (IPM) to treat patients with regenerative substances (autologous bone marrow stem cells and platelets) with repair capabilities into damaged and degraded tissues with advanced and precise interventional treatment. Including muscles, tendons, ligaments, cartilage and even nerves, to achieve the purpose of repair and regeneration, to rebuild the stability of the spine and joints, to improve or even cure chronic cervical pain, chronic lower back pain, various degenerative arthritis and soft tissue damage.
Platelet lysate (PL)
The use of platelet lysate (PL) in 2005 has evolved into the fourth generation for the treatment of various musculoskeletal injuries.
SCP is more purified than normal PRP components, and can be used to tailor the amount and concentration required for each patient to treat muscle, ligament tendon inflammation and laceration, mild degenerative arthritis, which can help stimulate stem cells to work harder to repair damaged tissue.
Interventional Pain Management (IPM)
The regenerative substances (autologous bone marrow stem cells and platelets) with repair ability are injected into the damaged and degraded tissues by advanced and precise interventional treatment.