Summary

quality assessment of tissue biopsy for tendon cell injection

Abstract

Introduction

Autologous tendon cell injection (ATI) is a promising non-surgical treatment for tendinopathies and tendon tear that address its underlying pathology. Proof-of-concept preclinical animal studies and clinical studies demonstrated promising results regarding the healing of tendon structure, and significant clinical improvements in pain, strength and functional outcome measures. Current procedure of ATI involves harvesting autologous tendon tissue, the isolation of the tendon cells, expansion under quality assured GMP cell laboratory and the injection of the tendon cells via U/S into the degenerative tendon tissue. In clinical practice, the patella (PT) and palmaris longus (PL) tendons are common sites used for tendon tissue biopsy. The objective of this study is to compare the tendon cell quality, identity, purity, doubling time and yield of cells between PT and PL tendons for ATI.

Methods

Tendon tissue biopsies were harvested from PT via U/S using a 14-gauge needle or resected surgically from the PL tendon. The biopsies were transported to a GMP cell laboratory, where tendon cells were isolated, cultured and expanded for 4 to 6 weeks, and analysed for viability, cell doubling time, cellular characteristics including cell purity, potency and identity (PPI).

Results

Tendon samples from 149 patients were analysed (63 PT). Average biopsy weight was 62mg for PT and 119mg for PI (p<0.001). Average cell doubling time (83.9 vs 82.7 hours), cellular yield (16.2 vs 15.2x106), viability (98.7 vs 99.0%) and passage number (3 vs 3) were not significantly different between tendons. Additionally, ddPCR analyses showed no differences of PPI including tendon cell markers of collagen type I, scleraxis and tenomodulin. No post-biopsy complications or contamination were reported for either group. Assessing tendon tissue from palmaris tendon is relatively easier.

Conclusion

Tendon-derived cell therapy has been used for treatment of late-stage tendinopathy and tear in different anatomical sites including elbow, gluteal and rotator cuff in Australia. The mechanisms of action are multi-factorial including 1) to replenish the local tendon cell population; 2) to promote tissue regeneration by counteracting the intrinsically slow healing process; and 3) to stimulate the production of growth factors and the synthesis of matrix proteins The result of this study has showed that tendon tissue biopsy for autologous tendon cell therapy can be obtained from either the PT or PL tendons. Tendon cells isolated from PT and PL were equal in growth characteristics and PPI. There are no differences in the quality of tendon cells isolated from the PT or PL.