Compassionate Use in stem Cell Therapies

Compassionate Use in Stem Cell Therapies

The ICMS recognizes that there are patients who cannot wait for stem cell therapies to become a mature treatment.  For these patients with terminal illnesses, death or severe disability will almost certainly occur before large scale, randomized controlled trials are complete.  As such, ICMS condones the use of compassionate ASC stem cell treatments (of the type described in this document, autologous, minimal culture expansion, homologous use, physiologic cell culture) under a narrowly defined set of guidelines. 

To qualify for compassionate use the patient must:

Have been given a diagnosis of a likely fatal illness.  Examples include COPD, Coronary Artery Disease, and Congestive Heart Failure.
Have a written statement from a board certified physician in the same area of specialty of the likely fatal disease that states that the patient is end stage with an incurable disease, that no other types of care are available or other reasonable alternatives have failed, and the patient’s condition is expected to worsen.

If these conditions are met, the patient can be treated with a PICL (see Clinical Staging Process) or greater without restriction.  As with the PICL line definition, multiple animal models must be available showing efficacy with the cell line.  The patient must also have his/her treatment approved by an IRB to ensure patient protections.