Signed into law in 2018, this Act allows patients with life-threatening conditions to access certain unapproved treatments, including some stem cell therapies, outside of clinical trials. Key points include:

• Eligibility for patients who have exhausted approved treatment options and cannot participate in clinical trials

• Requires only Phase 1 safety trials to be completed

• Bypasses certain FDA approval processes for experimental treatments

Passed in 2016, this Act aims to accelerate medical product development and bring innovations to patients faster. It includes provisions for:

• Expedited review processes for regenerative medicine advanced therapies (RMAT)

• Increased funding for research in regenerative medicine

Introduced in 2017, this framework aims to:

• Provide clarity on which regenerative medicine products are subject to FDA premarket review

• Streamline and expedite the approval process for certain regenerative medicine therapies

Passed in 2017, this state-level bill:

• Allows patients with chronic and terminal illnesses to access stem cell treatments that have completed FDA Phase 1 safety trials

• Requires treatments to be administered by physicians at medical facilities

• Mandates informed consent from patients

While not regulatory in nature, these guidelines influence policy and practice:

• Provide ethical and scientific standards for stem cell research and clinical translation

• Updated periodically to address emerging issues in the field

Despite these advancements, challenges remain:

• Balancing safety concerns with the need for innovative treatments

• Harmonizing regulations across different countries

• Addressing the rise of unproven stem cell treatments and medical tourism

The regulatory landscape continues to evolve, with potential developments including:

• Further refinement of expedited approval pathways for regenerative medicine

• Increased international collaboration on regulatory standards

• Development of more specific guidelines for MSC-based therapies

As the field of MSC therapy advances, it's crucial for patients, researchers, and healthcare providers to stay informed about these regulatory developments. They play a significant role in shaping the accessibility and safety of these promising treatments.