Cell therapy in orthopaedics: where are we in 2019?

Area of Science:

• Regenerative Medicine
• Cell Therapy
• Tissue Engineering

Background:

• Basic laboratory studies show strong potential for cell therapies in tissue healing and regeneration.
• Limited scientific evidence exists for many commercially available cell formulations used in patients.
• Aggressive marketing of unproven cell therapies by commercial entities causes confusion and unpredictable outcomes.

Purpose of the Study:

• To clarify the definition and application of stem cells in regenerative medicine.
• To address the confusion arising from the marketing and use of unproven cell therapies.
• To highlight the need for standardized definitions and validated methods for cell formulations.

Main Methods:

• Review of current scientific literature on cell therapy efficacy.
• Analysis of the heterogeneity and variability in available cell formulations.
• Discussion of the distinction between minimally manipulated and laboratory-processed cells.

Main Results:

• Significant variability exists in cell formulations, hindering efficacy conclusions.
• The term 'stem cells' should apply only to laboratory-purified, culture-expanded cells.
• Undiluted bone marrow and adipose tissue contain very few cells meeting these criteria.

Conclusions:

• Refined definitions for stem cells are necessary to reduce confusion.
• Validated methods are needed to characterize cell formulations and their biological activity.
• Future cell therapy success depends on basic, translational, and clinical research, with personalized approaches.