The ICMS Makes the following Recommendations for the Clinical Use of Stem Cells:

Cell Lines: Every stem cell line must be registered and tracked according to the clinical staging process of the ICMS.

The ICMS guidelines do not permit the use of PICL or EICL cell lines in routine clinical practice. All research protocols using EICL and LICL cell lines should be approved by an Institutional Review Board.
ECCL and LCCL cell lines can be used in early clinical practice with the above noted restrictions.  
Stem cell lines designated as Clinical Grade alone have unrestricted clinical use with regard to numbers of patients allowed for treatment.

To review the ICMS Cell Line Staging Process, click HERE

Re-Implantation Registry: Every patient being treated with a registered cell line must be entered into the ICMS Re-implantation registry for long-term tracking and follow-up.

Quality Control: To ensure that any negative treatment outcome of an adult stem cell culture process can be appropriately tested and tracked, ICMS recommends the use of a QA sample saved in cryo-storage (-150 C) for every completed cell culture.  This is in addition to the exemplar lines stored as part of the ICMS Reimplantation Registry.

Complications: Significant complications are defined as an impairment of health or a condition of abnormal functioning that is directly caused by stem cell re-implantation. This does not include direct procedural complications such as infection, inflammation, tissue damage physically caused by the re-implantation, or manipulation of tissue. While these procedural complications should be recorded and could be used in the overall assessment of procedure safety, they are not considered as directly related to the stem cell line.

Blinded Trials: A blinded standard is not necessary for this phase of research. However, there should be measurement of both clinical outcomes and objective imaging or other objective changes.  The ICMS advises all physicians to conduct blinded clinical trials. ICMS will facilitate the pooling of resources between ICMS physicians to allow these trials to be undertaken so that insurance reimbursement can be sought for therapies that pass this level of evidence.