Stayble Therapeutics AB

The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are:
1. Is the treatment safe and tolerable?
2. Does the volume of the disc and the herniation decrease?
3. Is sciatica reduced? Participants will be given an injection into the herniated disc of either placebo or STA363 (one dose).
Researchers will compare safety, tolerability, effects on disc and herniation volume and on symptoms between the group of patients injected with placebo and the group injected with STA363.

This is a phase IIb, prospective, multi-country, multicenter, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and transformation of NP following single intradiscal injection of STA363 (lactic acid) into one or two IVDs compared to placebo for the treatment of discogenic low back pain. This study will be conducted in Russia, Spain and the Netherlands.

A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intradiscal injection of STA363 or placebo in patients with discogenic low back pain.
15 patients will participate in either of 3 dose groups, each comprising 5 patients:
* Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)
* Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)
* Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)