The RESPINE trial completed its recruitment. One hundred and thirteen patients received treatment between March 2019 to April 2021 at 9 clinical trial sites across four different countries (France, Spain, Germany and Italy).
RESPINE is a multicentre, randomized, controlled, phase 2b clinical trial that aims to assess the efficacy of an allogeneic intervertebral mesenchymal stromal stem cell (MSC)-based therapy in patients with Degenerative Disc Disease (lower back pain). The World Health Organisation has included low back pain in its list of twelve priority diseases. Today, no efficient therapy is available. This innovative therapy intends to rapidly (within 3 months) and sustainably (for at least 24 months) reduce pain and disability.
The patients recruited to the trial are followed for two years after treatment. The first patients included in the trial have just completed their follow-up period and the last will exit the monitoring stage in two years.
RESPINE project is funded by the Horizon 2020 program (GA N°732163) and coordinated by the CHU of Montpellier (France). ECRIN is involved in the regulatory and monitoring activities in the European countries.