This is how lab personnel can exceed expectations

The path to developing stem cell therapy product goes through many hoops and difficulties such as funding, facility, or equipment. But one element presents itself as the most precious, and the most difficult to provide, cells; yes cells. Cells are in the center of every cell therapy product. The difficulty rises from attempting to develop a new product using a “representative” cell sample that best mirror the clinical situation. In this post we will talk about sources of cells and how to make them available for researchers.

Approvals

Before we go through that, we need to set the stage by talking about a very important mandate, approvals. The first step in providing cells for development is to get the appropriate approvals.

• Institutional Review Board (IRB): each institution has an IRB, or an equivalent body, that ensures the research is done in an ethical way that harms no research participant. The approval of such review body is needed before making any cells or cells source available for research.
• Consent: IRB approval also mandates proper consenting process for participants. Consenting include patients and donors and clearly inform them of how their cells could be utilized, and give them the right to decline.

Assuming approvals are granted, and consents are signed, what cell sources are available for researchers?

Cell Sources

A. Blood centers (blood banks): normally, the majority of blood collections are used to infuse patients, but few collections are not used; here is why:

1. Quantity not sufficient (QNS): are blood collections that were discontinued for any reason and ended as below the standard collection volume; such units are typically marked for disposal.
2. Therapeutic collections: for some patients, routinely donating blood alleviate their disease symptoms. These patients donate their blood, but these blood unit are marked for disposal & not infusion due to the donors’ medical status.

B. Donations: Healthy donors have the opportunity to donate for research, they can donate:

1. Stem Cells (mobilized/ immobilized).
2. Whole Blood Sample.
3. Cord Blood.

C. Repositories: specialized laboratories can recruit donors, collect, and cryopreserve different cell types at different volumes and concentrations to build a repository. Researchers can then purchase samples that fit their research quality and quantity needs.

How it works

We have talked about approvals and cell sources, but for these elements to work, they need a system that puts them together in a coordinated manner:

a) Blood banks or repositories would seek an IRB approval for their use of cells. Once approved, these entities can make the cells available to researchers.

b) Researchers would seek an IRB approval for their research anyway, this time the difference is using the IRB approved cell source.

c) A mechanism for healthy donors to donate their cells for research use, including the right consent. This applies to patients who consent for the research use of their extra or expired cells.

Many cells like QNS units, therapeutic collections, or expired cells are discarded. While in fact these cells are very valuable and can contribute to research and development in a significant way. With the right approval and mechanism in place these cells are not wasted.

Let us know if we missed anything, or if you would like a specific subject to be discussed, write to us.