Stem Cell Advances Focus on Heart, Inflammation
For decades, scientists have been working to develop medical therapies from the body's own stem cells. Promising new treatments are finally moving through clinical trials in conditions ranging from heart disease and inflammation to eye diseases and diabetes.
While it is too early to predict winners, here are some of the programs that are likely to attract attention in the coming years:
* Aastrom Biosciences Inc is due to start a Phase III trial of its treatment for critical limb ischemia (CLI), a severe form of peripheral artery disease. Aastrom uses cells derived from a patient's own bone marrow. The company is also conducting Phase II trials of the drug in patients with dilated cardiomyopathy, an end-stage form of heart failure.
* Athersys Inc is developing a product known as MultiStem using stem cells obtained from donors' bone marrow and other tissue. It is being tested in four human clinical trials: ulcerative colitis, heart attack, ischemic stroke and complications from bone marrow or stem cell transplants. Athersys has a deal with Pfizer Inc to develop MultiStem for treating inflammatory bowel disease.
* Baxter International Inc is studying the use of patients' own bone marrow stem cells to treat heart problems, including severe angina, or chest pain. The company is planning a Phase III trial.
* Celgene Corp uses cells from human placentas and expects to announce in mid-2012 results from Phase II trials in Crohn's disease and rheumatoid arthritis. It is also conducting a mid-stage trial in stroke patients.
* Cytori Therapeutics Inc is using fat cell-derived stem and regenerative cells to develop treatments for heart disease and reconstructive surgery. To treat heart attack, a small amount of fat tissue is removed shortly after the heart attack. Stem and regenerative cells are separated and concentrated. The cells are infused into the coronary artery to increase blood flow.
* Fibrocell Science Inc, a company that is traded over the counter, received U.S. approval earlier this year for Laviv, its stem cell-based treatment for smile wrinkles. The product is made by extracting and multiplying a person's own collagen-making cells, and injecting them at the wrinkle site.
* Gamida Cell is in a joint venture with Teva Pharmaceutical Industries to develop StemEx for patients with blood cancers such as leukemia and lymphoma who cannot find a matched bone marrow donor. The Israel-based companies are conducting a Phase III trial of StemEx, a graft of stem cells from umbilical cord blood.
* Mesoblast Ltd is developing therapies for cardiovascular conditions, diabetes, inflammatory conditions and other disorders. U.S. regulators recently approved a Phase III study using Mesoblast cells in patients needing bone marrow transplants.
* NeoStem Inc is developing a product to prevent further tissue damage in patients who have suffered a heart attack. The company expects to begin a Phase II study of AMR-001 in the first quarter of 2012. NeoStem isolates repair cells from a patient's own bone marrow and inserts them through a stent in the previously-blocked artery. The cells then migrate into the healthy tissue that surrounds the damaged area, increasing the supply of oxygen and nutrients.
* Neuralstem Inc is targeting neurodegenerative diseases such as stroke, Alzheimer's, spinal cord injury and Parkinson's disease. The company uses stem cell lines derived from human fetal tissue.
* Osiris Therapeutics Inc is developing treatments for inflammatory, autoimmune, orthopedic and cardiovascular diseases using bone-marrow-derived stem cells. Its drug Prochymal is being tested in Phase III trials for acute graft versus host disease (GvHD) and Crohn's disease.
* Pharmicell Co Ltd, listed in South Korea, produces Heartcellgram-AMI for heart attack patients. The treatment, based on stem cells extracted from the patient's bone marrow, was approved by Korean health regulators.
* Pluristem Therapeutics Inc is using cells from human placentas for a range of diseases, including peripheral artery disease. Pluristem has also licensed its PLX (placental expanded) cells to United Therapeutics Corp to develop a treatment for pulmonary hypertension.
* StemCells Inc is working on therapies to treat damage or degeneration of major organ systems. The company plans to seek regulatory approval by year-end for a trial of the therapy in the dry form of age-related macular degeneration.