Principal Investigator Dr Mark Kotter and Co-Principal Investigator Dr Ben Davies are excited to announce the launch of the first regenerative medicine trial for Degenerative Cervical Myelopathy (DCM) at Cambridge University Hospitals. RECEDE-Myelopathy is a phase 3, double blind, randomised controlled trial. The first phase is funded by the NIHR and supported by Medicinova. Recruitment is now ongoing in Cambridge UK.
The trial will evaluate whether Ibudilast, a phosphodiesterase 3/4 inhibitor, can improve recovery after surgical decompression. Clinical and preclinical findings indicate that the drug Ibudilast can stimulate neuroprotective and regenerative processes in the spinal cord. Ibudilast is well tolerated and used to treat asthma and post-stroke dizziness in Japan and is currently being investigated for use in treating other neurological diseases.
This study will investigate whether daily oral administration of Ibudilast for a maximum of 34 weeks can improve hand function, strength, balance, urinary problems, and reduce pain.
Individuals between 18 and 80 years old, diagnosed with DCM and scheduled for an operation for the first time, will be invited to participate in the trial. The study will involve patient questionnaires and clinical assessments before surgery, shortly after surgery and 3, 6, and 12 months after surgery. Moreover, patients will undergo MRI scans pre-operatively and at 6 months postoperatively to determine whether the treatment was successful.
The study will initially be conducted at three sites in the UK, with more sites added as necessary.
Any centres in the UK (or centres in Europe which can self-fund) are invited to participate in this important study for DCM. If you would like to join us, please email recode@myelopathy.org.