Traumatic Brain Injury TBI
Conditions
Interventions
- Injection of cell therapy drug (Acuugo intracerebral implant injection) into the skull around the brain injury site via surgery (treatment group only)
- Periodic rehabilitation (treatment group, con
Sponsors
Mitsuru Tsumori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18-75 years with a history of TBI - At least 6 months after TBI injury - Patients (with or without concomitant diffuse axonal injury) with brain injury with focal lesions that can be identified by MRI and motor dysfunction resulting from the lesion. - Patients with an Upper extremity Scale of 10-81 on the score of Motricity Index, of whom at least two scores less than 33, one score less than 25, at least one score greater than 0, and patients with a Lower extremity Scale of 10-78, among whom at least two scores less than 33, one score less than 25, and at least one score greater than 0, moderate to severe paralysis - Glasgow Outcome Scale Extended (GOS-E) Moderate or severe patients with a score of 3-6 - Patients who are willing to participate and continue in the rehabilitation program of the study
Exclusion criteria
Exclusion criteria: - Patients with any joint that has contractures that cannot be assessed neurologically (e.g., contractures that interfere with the detection of increased range of motion or ability to perform tasks) - Patients with other neurological, neuromuscular or orthopedic diseases that limit motor function - Patients with clinically predominant findings not related to TBI in cerebral MRI - Patients who have received botulinum toxin injections, phenol injections, intrathecal baclofen, or other interventional treatments for spasticity (excluding fixation devices and splinting) within 16 weeks before the baseline visit (interventional treatment refers to treatment with specialized devices commonly performed in centers performing surgery or procedures, not applicable to oral administration of baclofen, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in FMMS at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean change from baseline in FMMS at Week 48 - Mean change from baseline in FMMS score (upper extremity) and FMMS score (lower extremity) at Weeks 24 and 48 - Mean change from baseline in FIM motor item-score at Weeks 24 and 48 - Mean change from baseline in FIM total scores at Weeks 24 and 48 | — |
Contacts
Public ContactIsobe Ryohei
SanBio Co.,Ltd.
Outcome results
None listed