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Table 3 Key limitations and barriers

From: Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials

Lack of international coordination

• Complex and diversified regulatory landscape

• Variations and incompatibilities

Uncertainty and lack of clarity in regulations

• Difficult to read and understand

• Lack specificity and clarity

Organizational complexity from interactions with medical authorities and regulatory entities

• Information available online not always current or user-friendly

• Requirements vary by country and regulatory authority

Costs and infrastructure requirements

• Lack compatible infrastructure across clinical trial sites

• Funding and disproportionate financial burden (academia)

Cultural and logistical disparities

• Variations in ethical (e.g. REB approval), confidentiality and privacy requirements from country to country

Unproven therapies

• Small number of approved cellular therapies on the market

• High price tag

• Gaps in oversight and enforcement of such mechanisms