Table 2 Steps towards clinical application

From: Discoveries from human stem cell research in space that are relevant to advancing cellular therapies on Earth

Steps

Goals and objectives

Estimated time frame

Pre-clinical studies needed for generation of space grown cells

• Identity: ensure that the basic identity of space grown stem cells has not significantly changed because of exposure to the space environment.

• Purity: characterize the space grown stem cells to ascertain the product’s cell composition describing the proportion of stem cells and other differentiated cells.

• Sterility: assess the presence of any microbial contamination such as human transmissible bacteria, fungal, known and unknow viral organisms and other adventitious agent.

• Safety: determine the safety of space grown stem cells usually in-vitro to assess DNA damage, chromosomal abnormalities, tumorigenicity and in-vivo to assess toxicity, cell distribution and fate.

• Potency: evaluate the functional and therapeutic effectiveness of the space grown cells that align with the intended use. This usually involves the use of in-vitro 2D or 3D cell culture system and in-vivo animal models.

3–10 years

Phase I safety clinical trial

A small study involving 5–15 patients with the targeted condition or disease to evaluate the safety of space grown stem cells.

1–2 years

Phase II efficacy clinical trial

A randomized controlled study involving 30–100 patients that shows efficacy of the space grown stem cells relative to control.

2–3 years

Phase III comparison to available treatment

A larger study comparing space grown stem cells with the best available Earth grown stem cells.

3– 4 years

Commercial licensure

Review of data and issue of a commercial licensure.

1–2 years

 

Total estimated time frame

10–21 years

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