Table 1.

Key recommendations for successful clinical translation of injectable cell‐based disc therapies

Safety	Efficacy	Commercial viability	Engaging clinicians
Demonstrate long term retention in the disc space under physiological loading	Select experimental outcomes relevant to the overall goal of long term alleviation of symptoms through stabilization/ restoration of disc structure and biomechanical function	Identify the size of the prospective target patient population	Engage clinicians early and continuously during development
Evaluate acute and chronic, local and systemic toxicity in vitro and in vivo, and include effects of degradation products	Apply model systems iteratively, balancing experimental control, cost and throughput in the early stages with biological complexity and clinical relevance at more advanced stages	Protect intellectual property early by submitting an invention disclosure to the relevant university office	Anticipate resistance to switching away from current therapeutic approaches
Minimally invasive delivery carries less risk than an open surgical approach	Design model systems to appropriately mimic aspects of the in vivo chemical, physical and mechanical microenvironments of the disc	Minimize cost and complexity with respect to production, preparation and administration	Clinicians can provide primary human sourced material for in vitro testing, and develop and refine techniques for in vivo modeling and therapeutic administration
Aim for a single administration vs multiple administrations	Consider the confounding effects of species, age and sex on efficacy in vitro and in animal models	Minimize the number of potential regulatory hurdles	Clinicians can advise and lead design and implementation of clinical trials, including patient recruitment
Maximize genetic stability of stem cell therapies by minimizing in vitro manipulation	Incorporate human‐sourced cells and tissues into experiments	Undertake a comprehensive survey of the competitive landscape	Clinicians can advocate new therapeutic approaches to patients and health systems, accelerating their early and widespread adoption
Autologous cell therapies pose less of a risk than allogeneic	Where outcomes such as pain or mechanical properties cannot be measured directly, carefully justified, clinically relevant surrogates should be used		Clinicians can facilitate dissemination and promotion of new therapeutic approaches to colleagues at clinical scientific meetings
	Clearly define success benchmarks for all experimental outcomes