AD Levine - Regenerative Medicine, 2012 - Future Medicine

Improving oversight of innovative medical interventions in Texas, USA.

Stem career interventions

Levine

GSID: MJqMeFC3YJQJ

Excerpt

The rules also require that the administration of investigational agents, such as SCBIs, be part of a systematic and competently designed program to evaluate their efficacy and safety. Requirements for these evaluations include informed consent of all participants, the provision to all participants of a written description of the goals of the study, including the distinction between the goals of the clinical research study and the goals, risks and benefits of the treatment, and written disclosure to participants if the use of placebos are involved.

Similar articles

Progressive approval: a proposal for a new regulatory pathway for regenerative medicine.

[No authors listed]
AI Caplan, MD West - Stem Cells Translational Medicine, 2014 - Wiley Online Library
GSID: b4Y2vN4vR20J

Cited by

Oversight for clinical uses of autologous adult stem cells: lessons from international regulations.

Capps BJ, Kerridge I, Lysaght T, Sipp D.
T Lysaght, I Kerridge, D Sipp, G Porter, BJ Capps - Cell Stem Cell, 2013 - Elsevier
GSID: k8R-0WobGAwJ

Global bionetworks and challenges in regulating autologous adult stem cells.

Kerridge I, Lysaght T, Sipp D.
T Lysaght, I Kerridge, D Sipp, G Porter… - The American Journal of …, 2013 - amjmed.com
GSID: w6RBtpyO9LwJ