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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