Autologous tenocyte injection for the treatment of chronic recalcitrant gluteal tendinopathy: A prospective pilot study

Thomas A. Bucher, Jay R. Ebert, Anne Smith, William Breidahl, Michael Fallon, Tao Wang, Ming Hao Zheng, Gregory C. Janes

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background: Gluteal tendinopathy is a common cause of lateral hip pain, and existing conservative treatment modalities demonstrate high symptom recurrence rates. Autologous tenocyte injection (ATI) is a promising cell therapy that may be useful for the treatment of gluteal tendinopathy. Purpose: To investigate the safety and effectiveness of ATI, specifically in patients with chronic recalcitrant gluteal tendinopathy. Study Design: Case series; Level of evidence, 4. Methods: Twelve female patients with a clinical and radiological diagnosis of gluteal tendinopathy were recruited. Patients demonstrated a mean duration of symptoms of 33 months (range, 6-144 months), had undergone a mean 3.2 prior corticosteroid injections (range, 2-5), and had failed to respond to existing conservative treatments including physiotherapy and injections. In an initial procedure, tendon cells were harvested from a needle biopsy of the patella tendon and propagated in a certified Good Manufacturing Practice (GMP) laboratory. In a secondary procedure, a single injection of 2 mL autologous tenocytes (2-5 x 106 cells/mL) suspended in patient serum was injected into the site of the pathological gluteal tendons under ultrasound guidance. Patients were assessed preand postinjection (3, 6, 12, and 24 months) using the Oxford Hip Score (OHS), a visual analog pain scale (VAS), the Short Form-36 (SF-36), and a satisfaction scale. Magnetic resonance imaging (MRI) was undertaken at 8.7 months (range, 6-12 months) postinjection. Results: Molecular characterization of autologous tendon cells showed a profile of growth factor production in all cases, including platelet-derived growth factor α, fibroblast growth factor β, and transforming growth factor β. The OHS (mean, 24.0 preinjection to 38.9 at 12 months [14.9-point improvement]; 95% CI, 10.6-19.2; P <.001), VAS (mean, 7.2 preinjection to 3.1 at 12 months [4.1-point improvement]; 95% CI, 2.6-5.6; P <.001), and SF-36 (mean, 28.1 preinjection to 43.3 at 12 months [15.2-point improvement]; 95% CI, 9.8-20.5; P <.001) significantly improved to 12 months postinjection, sustained to 24 months. Eight patients were satisfied with their outcomes. Significant MRI-based improvement could not be demonstrated in the majority of cases. Conclusion: ATI for gluteal tendinopathy is safe, with improved and sustained clinical outcomes to 24 months.

Original languageEnglish
Article number2325967116688866
Number of pages10
JournalOrthopaedic Journal of Sports Medicine
Volume5
Issue number2
DOIs
Publication statusPublished - 21 Feb 2017

Fingerprint

Tendinopathy
Prospective Studies
Injections
Tendons
Hip
Pain Measurement
Therapeutics
Magnetic Resonance Imaging
Patellar Ligament
Fibroblast Growth Factors
Platelet-Derived Growth Factor
Transforming Growth Factors
Needle Biopsy
Cell- and Tissue-Based Therapy
Intercellular Signaling Peptides and Proteins
Adrenal Cortex Hormones
Safety
Recurrence
Pain
Serum

Cite this

Bucher, Thomas A. ; Ebert, Jay R. ; Smith, Anne ; Breidahl, William ; Fallon, Michael ; Wang, Tao ; Zheng, Ming Hao ; Janes, Gregory C. / Autologous tenocyte injection for the treatment of chronic recalcitrant gluteal tendinopathy : A prospective pilot study. In: Orthopaedic Journal of Sports Medicine. 2017 ; Vol. 5, No. 2.
@article{f307a0dcaa21470c9adf2356b3d7cc63,
title = "Autologous tenocyte injection for the treatment of chronic recalcitrant gluteal tendinopathy: A prospective pilot study",
abstract = "Background: Gluteal tendinopathy is a common cause of lateral hip pain, and existing conservative treatment modalities demonstrate high symptom recurrence rates. Autologous tenocyte injection (ATI) is a promising cell therapy that may be useful for the treatment of gluteal tendinopathy. Purpose: To investigate the safety and effectiveness of ATI, specifically in patients with chronic recalcitrant gluteal tendinopathy. Study Design: Case series; Level of evidence, 4. Methods: Twelve female patients with a clinical and radiological diagnosis of gluteal tendinopathy were recruited. Patients demonstrated a mean duration of symptoms of 33 months (range, 6-144 months), had undergone a mean 3.2 prior corticosteroid injections (range, 2-5), and had failed to respond to existing conservative treatments including physiotherapy and injections. In an initial procedure, tendon cells were harvested from a needle biopsy of the patella tendon and propagated in a certified Good Manufacturing Practice (GMP) laboratory. In a secondary procedure, a single injection of 2 mL autologous tenocytes (2-5 x 106 cells/mL) suspended in patient serum was injected into the site of the pathological gluteal tendons under ultrasound guidance. Patients were assessed preand postinjection (3, 6, 12, and 24 months) using the Oxford Hip Score (OHS), a visual analog pain scale (VAS), the Short Form-36 (SF-36), and a satisfaction scale. Magnetic resonance imaging (MRI) was undertaken at 8.7 months (range, 6-12 months) postinjection. Results: Molecular characterization of autologous tendon cells showed a profile of growth factor production in all cases, including platelet-derived growth factor α, fibroblast growth factor β, and transforming growth factor β. The OHS (mean, 24.0 preinjection to 38.9 at 12 months [14.9-point improvement]; 95{\%} CI, 10.6-19.2; P <.001), VAS (mean, 7.2 preinjection to 3.1 at 12 months [4.1-point improvement]; 95{\%} CI, 2.6-5.6; P <.001), and SF-36 (mean, 28.1 preinjection to 43.3 at 12 months [15.2-point improvement]; 95{\%} CI, 9.8-20.5; P <.001) significantly improved to 12 months postinjection, sustained to 24 months. Eight patients were satisfied with their outcomes. Significant MRI-based improvement could not be demonstrated in the majority of cases. Conclusion: ATI for gluteal tendinopathy is safe, with improved and sustained clinical outcomes to 24 months.",
keywords = "Autologous tenocyte implantation, Cellular therapy, Clinical outcomes, Gluteal tendinopathy, Greater trochanteric pain syndrome",
author = "Bucher, {Thomas A.} and Ebert, {Jay R.} and Anne Smith and William Breidahl and Michael Fallon and Tao Wang and Zheng, {Ming Hao} and Janes, {Gregory C.}",
year = "2017",
month = "2",
day = "21",
doi = "10.1177/2325967116688866",
language = "English",
volume = "5",
journal = "Orthopaedic Journal of Sports Medicine",
issn = "2325-9671",
publisher = "SAGE Publications Ltd",
number = "2",

}

Autologous tenocyte injection for the treatment of chronic recalcitrant gluteal tendinopathy : A prospective pilot study. / Bucher, Thomas A.; Ebert, Jay R.; Smith, Anne; Breidahl, William; Fallon, Michael; Wang, Tao; Zheng, Ming Hao; Janes, Gregory C.

In: Orthopaedic Journal of Sports Medicine, Vol. 5, No. 2, 2325967116688866, 21.02.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Autologous tenocyte injection for the treatment of chronic recalcitrant gluteal tendinopathy

T2 - A prospective pilot study

AU - Bucher, Thomas A.

AU - Ebert, Jay R.

AU - Smith, Anne

AU - Breidahl, William

AU - Fallon, Michael

AU - Wang, Tao

AU - Zheng, Ming Hao

AU - Janes, Gregory C.

PY - 2017/2/21

Y1 - 2017/2/21

N2 - Background: Gluteal tendinopathy is a common cause of lateral hip pain, and existing conservative treatment modalities demonstrate high symptom recurrence rates. Autologous tenocyte injection (ATI) is a promising cell therapy that may be useful for the treatment of gluteal tendinopathy. Purpose: To investigate the safety and effectiveness of ATI, specifically in patients with chronic recalcitrant gluteal tendinopathy. Study Design: Case series; Level of evidence, 4. Methods: Twelve female patients with a clinical and radiological diagnosis of gluteal tendinopathy were recruited. Patients demonstrated a mean duration of symptoms of 33 months (range, 6-144 months), had undergone a mean 3.2 prior corticosteroid injections (range, 2-5), and had failed to respond to existing conservative treatments including physiotherapy and injections. In an initial procedure, tendon cells were harvested from a needle biopsy of the patella tendon and propagated in a certified Good Manufacturing Practice (GMP) laboratory. In a secondary procedure, a single injection of 2 mL autologous tenocytes (2-5 x 106 cells/mL) suspended in patient serum was injected into the site of the pathological gluteal tendons under ultrasound guidance. Patients were assessed preand postinjection (3, 6, 12, and 24 months) using the Oxford Hip Score (OHS), a visual analog pain scale (VAS), the Short Form-36 (SF-36), and a satisfaction scale. Magnetic resonance imaging (MRI) was undertaken at 8.7 months (range, 6-12 months) postinjection. Results: Molecular characterization of autologous tendon cells showed a profile of growth factor production in all cases, including platelet-derived growth factor α, fibroblast growth factor β, and transforming growth factor β. The OHS (mean, 24.0 preinjection to 38.9 at 12 months [14.9-point improvement]; 95% CI, 10.6-19.2; P <.001), VAS (mean, 7.2 preinjection to 3.1 at 12 months [4.1-point improvement]; 95% CI, 2.6-5.6; P <.001), and SF-36 (mean, 28.1 preinjection to 43.3 at 12 months [15.2-point improvement]; 95% CI, 9.8-20.5; P <.001) significantly improved to 12 months postinjection, sustained to 24 months. Eight patients were satisfied with their outcomes. Significant MRI-based improvement could not be demonstrated in the majority of cases. Conclusion: ATI for gluteal tendinopathy is safe, with improved and sustained clinical outcomes to 24 months.

AB - Background: Gluteal tendinopathy is a common cause of lateral hip pain, and existing conservative treatment modalities demonstrate high symptom recurrence rates. Autologous tenocyte injection (ATI) is a promising cell therapy that may be useful for the treatment of gluteal tendinopathy. Purpose: To investigate the safety and effectiveness of ATI, specifically in patients with chronic recalcitrant gluteal tendinopathy. Study Design: Case series; Level of evidence, 4. Methods: Twelve female patients with a clinical and radiological diagnosis of gluteal tendinopathy were recruited. Patients demonstrated a mean duration of symptoms of 33 months (range, 6-144 months), had undergone a mean 3.2 prior corticosteroid injections (range, 2-5), and had failed to respond to existing conservative treatments including physiotherapy and injections. In an initial procedure, tendon cells were harvested from a needle biopsy of the patella tendon and propagated in a certified Good Manufacturing Practice (GMP) laboratory. In a secondary procedure, a single injection of 2 mL autologous tenocytes (2-5 x 106 cells/mL) suspended in patient serum was injected into the site of the pathological gluteal tendons under ultrasound guidance. Patients were assessed preand postinjection (3, 6, 12, and 24 months) using the Oxford Hip Score (OHS), a visual analog pain scale (VAS), the Short Form-36 (SF-36), and a satisfaction scale. Magnetic resonance imaging (MRI) was undertaken at 8.7 months (range, 6-12 months) postinjection. Results: Molecular characterization of autologous tendon cells showed a profile of growth factor production in all cases, including platelet-derived growth factor α, fibroblast growth factor β, and transforming growth factor β. The OHS (mean, 24.0 preinjection to 38.9 at 12 months [14.9-point improvement]; 95% CI, 10.6-19.2; P <.001), VAS (mean, 7.2 preinjection to 3.1 at 12 months [4.1-point improvement]; 95% CI, 2.6-5.6; P <.001), and SF-36 (mean, 28.1 preinjection to 43.3 at 12 months [15.2-point improvement]; 95% CI, 9.8-20.5; P <.001) significantly improved to 12 months postinjection, sustained to 24 months. Eight patients were satisfied with their outcomes. Significant MRI-based improvement could not be demonstrated in the majority of cases. Conclusion: ATI for gluteal tendinopathy is safe, with improved and sustained clinical outcomes to 24 months.

KW - Autologous tenocyte implantation

KW - Cellular therapy

KW - Clinical outcomes

KW - Gluteal tendinopathy

KW - Greater trochanteric pain syndrome

UR - http://www.scopus.com/inward/record.url?scp=85014432894&partnerID=8YFLogxK

U2 - 10.1177/2325967116688866

DO - 10.1177/2325967116688866

M3 - Article

VL - 5

JO - Orthopaedic Journal of Sports Medicine

JF - Orthopaedic Journal of Sports Medicine

SN - 2325-9671

IS - 2

M1 - 2325967116688866

ER -