An Open, Randomized, Rehabilitation-controlled Study to Assess Safety, Tolerability, and Efficacy of Heparin Activated Recombinant Human Fibroblast Growth Factor 1 on a Biodegradable Device in Subjects with Traumatic Spinal Cord Injury
Phase of Trial: Phase I/II
Latest Information Update: 21 Feb 2018
At a glance
- Drugs SC 0806 (Primary)
- Indications Spinal cord injuries
- Focus Adverse reactions; First in man; Therapeutic Use
- Sponsors BioArctic
- 21 Feb 2018 According to a BioArctic media release, the company announced that it has received approval by the Estonian State Agency of Medicines, the Estonian Health Board for medical device and the local ethics committee for inclusion of Estonian patients in this study.It further stated that the Estonian patients will undergo treatment at the Karolinska University Hospital followed by a training period (18 mo).The rehabilitation will initially take place in Sweden and will then continue in Estonia.
- 02 Feb 2018 event According to a BioArctic media release, company has recieved funding from the European Union's Horizon 2020 Research and Innovation Program under Grant Agreement No. 643853 to perform a clinical study with SC0806.
- 02 Feb 2018 According to a BioArctic media release. first patient was treated in 2016 at Karolinska University Hospital, Sweden.