Traumatic Brain Injury. Diffuse traumatic brain injury
Conditions
Interventions
Intervention 1: Intervention group: Patients in this group will receive intra-carotid injections of allogeneic human dental pulp stem cells (hDPSCs) at a dose of 1 million cells/kg body weight in four
Sponsors
Kerman University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Severe traumatic brain injury with a Glasgow Coma Scale score between 5 and 7 Age between 18 and 70 years Non-penetrating TBI Trauma occurred less than 72 hours before obtaining consent TBI confirmed by CT scan (Marshall score >1) At least one reactive pupil present
Exclusion criteria
Exclusion criteria: Serious comorbidities or prior infections revealed by the patient’s medical history Previous moderate to severe brain injury Major psychiatric disorders Any neurological disorder or prior seizures requiring anticonvulsant therapy Evidence of prolonged hypoxic exposure Intracranial Pressure (ICP) greater than 40 mmHg on admission Hemodynamic instability despite continued fluid resuscitation and/or inotropic support Bilateral non-reactive mydriasis Unstable pelvic fracture requiring surgical fixation Spinal cord injury Positive urine pregnancy test Grade IV intra-abdominal injury (AAST classification) Weight of 130 kg or more Positive urine drug screen on admission Contraindications to MRI present
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effectiveness. Timepoint: One week, One month, 6 months after intervention. Method of measurement: Glasgow Outcome Scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Hojati
Kerman University of Medical Sciences
Outcome results
None listed