Low Back Pain Clinical Trial
Official title:
Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (Clinical Trial)
This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.
The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem
cell implantation therapy in intervertebral disc degeneration patients.
The use of allogenic mesenchymal stem cells from the umbilical cord was chosen because
patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that
autologous mesenchymal stem cell administration is not possible in terms of taking the source
of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.
This study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA
and Frankel scale, as well as assessment of the widening of the lumbar region using the
Schober Test), changes in the structure of the intervertebral discs (through MRI examination
and grading the degree of intervertebral disc degeneration), conduction function spinal cord
nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the
quality of life status of patients using the Oswestry Disability Index.
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