Growth hormone therapy enhances recovery of patients with spinal damage

Growth hormone treatment combined with physical therapy over six months significantly improved sensory function in patients with complete spinal injuries. This research, presented at the European Congress of Endocrinology in Lisbon, is the first human study to investigate the link between spinal injuries and growth hormone deficiency (GHD). These findings could lead to life-improving treatments for patients with spinal injuries.

Although the cause is unknown, over 70% of patients with spinal injuries also produce less growth hormone from the pituitary gland, but few studies have investigated how this impacts recovery. Cell-based studies have shown that growth hormone is involved in regenerative and adaptive processes in neurons and only preliminary studies have examined this in animals or humans. Given the proposed role of growth hormone in neuronal growth and regeneration and that many spinal injury patients exhibit growth hormone deficiency (GHD), therapies restoring growth hormone levels during rehabilitation could enhance recovery.

In this study conducted at the Hospital Quiron-Teknon and Guttmann Institute in Barcelona, 18 patients with complete spinal injury and GHD were treated with growth hormone or placebo over a six month period. Growth hormone dosage was individually tailored to comparable levels and all subjects participated in physical exercise for two hours per day during the study. Motor and sensory recovery was assessed at three and six months, using standard tests of sensory and motor function for spinal injury.

Although only a small patient group was assessed, the results showed those treated with growth hormone had significant improvements in the measures of self-care and respiration and sphincter control at both three and six months. The growth hormone group also regained far more feeling below the site of spinal injury after six months of treatment compared with the placebo group.

Further work, with larger patient numbers, is required to confirm and extend these findings; to examine differences between acute, sub-acute and chronic spinal injuries, and to investigate treatment with different doses of growth hormone.

Dr Guillem Cuatrecasas, who led the study, said, “It is possible that optimisation of the therapy could improve recovery, at least for sensory perception, in the future.”

Dr Guillem Cuatrecasas continued, “We need to challenge the well-established concept in medicine, that an axon once injured cannot be repaired. Sensory recovery is critical for quality of life in these patients, for example to avoid pressure ulcers from wheelchair use, and funding will be critical to further this work.”

Abstract OC12.3

Recombinant Growth Hormone added to physical therapy in GH-deficient adults with complete (ASIA A) Spine Injury (EudraCT 2011-005377-23)

Guillem Cuatrecasas1, Hatice Kumru2,3, MºJosep Coves1, Ioana Patrascioiu1, Josep Vidal2,3

1Dpt. Endocrinology, Hospital Quiron-Teknon, Barcelona, Spain, 2Fundación Institut Guttmann, Badalona, Spain, 3, Institut Universitari de Neurorehabilitació (UAB), Badalona, Spain

Introduction: Although in-vitro models suggest GH-induced differentiation, migration and survival of astrocytes and oligodendrocytes, no studies had been published in-vivo. We want to evaluate the efficacy and safety of GH associated with physical therapy compared to placebo in patients with complete spine injury (SI) and associated GH deficiency (GHD).

Methods:18 Patients with complete SI were screened for GHD (glucagon test). 12 severe (GH<3ng/ml) or partial (<10ng/ml) GHD were randomized in a double-blind placebo-controlled study. Motor and sensory ASIA scale, SCIM-III (spinal cord injury independence measure), Ashworth (spasticity), Neuropathic Pain Scale and Quantitative Sensory tests were assessed. Patients received subcutaneous injections of placebo or GH (Nutropin®) 6 days/week IGF1- adjusted, in addition to intensive physical therapy 2h/day, for 6 months. Both groups were similar according to age, sex, BMI, waist circumference.

Results: Significant (p=0,05) improvement was observed in SCIM-III score at 3 months: 55.6 (14.4 SD) vs 74 (2.8 SD) and 6 months: 55.4 (14.2 SD) vs 73.5 (2.1 SD), comparing GH-treated group with placebo. A significant improvement in the electrical perception threshold from the 1st up to the 5th metamera below the SI site was observed on both sides after 6 months of treatment in the GH, but not in the placebo group. These differences were observed intra-individually (p=0.04 Friedman's test) and between groups (5th left level (p=0.023) and 5th right level (p=0.031), mixed linear model). No correlations with IGF1 were observed. No GH-related adverse events were reported.

Conclusions: Not studied so far, GHD seems very prevalent in SI. This is the first trial with complete SI and concomitant GHD. GH added to intense physical rehabilitation improved functional parameters (SCIM) and changes in sensory quantification up to 5 levels below SI. Larger studies should be performed to confirm a GH beneficial effect on sensitive pathways in SI.

Notes for Editors

For further information about the study please contact:

Gulliem Cuatrecasas, MD PhD

Hospital Quiron-teknon

Vilana 12, Barcelona

Spain

Email: gcuatrecasas@cpen.cat

Phone: +34933933155

The study “Recombinant Growth Hormone added to physical therapy in GH-deficient adults with complete (ASIA A) Spine Injury (EudraCT 2011-005377-23)”is an oral presentation at the European Congress of Endocrinology at the Centro de Congressos de Lisboa, in Lisbon, Portugal.

For other press enquiries please contact the ECE 2017 press office:

Lynsey Forsyth

Communications Manager

European Society of Endocrinology

Tel: (+44) (0)1454 642252

Mob: (+44) (0)7876824027

Email: lynsey.forsyth@bioscientifica.com

The European Congress of Endocrinology is held at the Centro de Congressos de Lisboa, 20-23 May 2017. View the scientific programme for further information.

At the European Society of Endocrinology (ESE), we’re working together to develop and share the best knowledge in endocrine science and medicine.

ESE represents a community of over 20,000 European endocrinologists, enabling us to inform policy makers on health decisions at the highest level through engagement in advocacy efforts across Europe. It is by uniting and representing every part of the endocrine community that we are placed in the best possible position to improve life for the patient.