Table 3.
Consensus Statements on Stem Cell Therapy
No. | Statement |
---|---|
1 | The progenitors contributing to tissue development, regeneration, and healing in each specific tissue must be identified. The mechanisms regulating this contribution must be characterized. |
2 | The optimum preparation of stem cells for each indication must be established in a systematic fashion. Considerations should include cell number, concomitant use of growth factors, predifferentization, and vehicle. |
3 | Mesenchymal stem cells isolated from different tissues must be compared to identify the most appropriate cell source for each specific indication. |
4 | The mechanism responsible for therapeutic effects observed in applications to date must be comprehensively characterized. |
5 | A standardized assay of stem cell efficacy is needed. |
6 | Methods for establishing proof of safety of stem cell therapy should be determined in collaboration with industry and regulatory agencies. This process may require evidence of phenotype stability or viability. |
7 | The most appropriate control for clinical studies evaluating stem cell therapy in each indication must be identified. |