Japan becomes first to approve stem cell therapies for Parkinson’s and heart failure

• Japan has granted world-first approval for two stem cell–based regenerative therapies, one for Parkinson’s disease and one for severe heart failure.
• The Parkinson’s treatment uses induced pluripotent stem cells (iPSCs) that are converted into dopamine-producing neurons and transplanted into the brain to replace cells lost during the disease.
• The heart failure therapy involves placing sheets of stem cell–derived heart muscle cells onto the heart, which may help restore cardiac function by promoting tissue repair and new blood vessel growth.
• Both therapies received conditional approval, meaning they can be used clinically while researchers continue to collect additional safety and effectiveness data from patients.

Stem cells are a special type of cell that can develop into many different cell types. Stem cell therapy, or regenerative medicine, uses these cells to repair, replace, or regenerate diseased or injured tissue.

Currently, only a few stem cell products have FDA-approval for use in the United States. These consist of blood-forming stem cells, or hematopoietic progenitor cells, that derive from umbilical cord blood. At present, these treatments are only available for people with cancers and disorders that affect the blood and immune system.

While these treatments hold immense promise for therapeutic interventions, stem cell-based therapies for all other conditions are still experimental.

However, Japan has approved two stem cell–based therapies for Parkinson’s disease and severe heart failure. The treatments, which rely on laboratory-grown cells to repair damaged tissues, could become the first commercially available therapies using induced pluripotent stem cells (iPSCs).