lmplantable Microsystem for the Adaptation of the Spinal Cord after Paraplegia - Subproject A: Chip development and clinical validation

Status:

completed 06/2014

Aims:

Aim of the project was to develop recent biochemical methods into a comprehensive concept for the treatment of paraplegia by adding a surgical procedure. The project focuses on the development and application of an innovative micro-mechanical system (mMS) designed to adapt spinal cord tissue by a vacuum and enable postsurgical supply of pharmaceuticals via micro channels.

Activities/Methods:

Based on microsystem technological procedures, connection elements were produced, consisting of a large number of parallel tubes and transverse channels. A moulding technique for bioresorbable materials had to be developed, which allows the form-consistent production of the microstructures. Systems were made in sizes for rats, minipigs and humans.

In the rat total transection model, combination treatments with the micromechanical system, pharmaceutic substances and human somatic stem cells were investigated. Longitudinal studies of immunhistochemical and axonal tracing procedures as well as locomotional function tests (open field test) were performed. Additionally, the degradation of resorbable systems was tested. In a pilot study, the surgical technique was transferred to the more human like model of the minipig. In one animal an operation including the application of the mMS and the postsurgical treatment over two weeks was realised.

Results:

In the completed project phase, several crucial aspects of the potential future therapy were investigated and tested successfully. The three components mMS, chondroitinase ABC and human somatic stem cells significantly improved locomotion and axonal growth through the injured region. A combination of the mMS and somatic stem cells showed the best results. Bioresorbable systems showed no adverse reaction. The successful work on the minipig model enables a next step towards a clinical application. The relation of the research project to the German statutory accident insurance (DGUV) is strengthened by the current results. A future clinical application, in the sense of treating injured patients with all available means, will reduce financial load of the statutory accident insurance. The support of a forced development of new treatment methods for the severe trauma of paraplegia is important for the German statutory accident insurance, especially as the statutory accident insurance hospitals are the main column of the treatment of spinal cord injured patients in Germany.

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