Table III.
Features of unproven cell therapies (modified with permission from Srivastava et al).15
| Feature |
|---|
| 1. Unclear scientific rationale to suggest potential efficacy |
| 2. Lack of understanding of the mechanism of action or the biological function to support clinical use |
| 3. Insufficient data from in vitro assays, animal models and clinical studies regarding the safety profile to support the use in patients |
| 4. Lack of a standardized approach to confirm quality and ensure consistency in cell manufacturing |
| 5. Inadequate information disclosed to patients to enable proper informed consent |
| 6. Use within non-standardized or non-validated administration methods |
| 7. Uncontrolled experimental procedures in humans |