Cerebral Palsy
Protocol
Biologic
Follow-up
Endpoint parameters
Neutrojen C 130 Supraselective
(Intrathecal- Lumbar spinal injection)
Neutrojen C 130 Proprietary biologic / Bone Marrow derived mononuclear cells (autologous trial)
1Y: 30D, 3M, 6M, 12M Baseline diagnostic tests, Gadolinium MRI Brain & Spine, tests for recognized genetic mutations, Gross Motor Function Classification System (GMFCS) scale, 25 foot walk test (ambulatory subjects), end-point MRI
Neurogenesis and Revascularization, GMFCS improvement, improved walking gate, walk-time, marked motor, sensory, cognitive, speech amelioration, improved bowel and bladder control, change in lesion volume
Inclusion criteria: Spastic Cerebral Palsy; (Ag15-30) Ultrasound/CTV/MRV negative for CCSVI, Spinal stenosis (Myelopathy) negative, no family history of CP, Fragile X syndrome, tuberous sclerosis, down syndrome and other chromosomal disorders, human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus, malignancies, bleeding tendencies, pneumonia, renal failure, severe liver dysfunction, severe anemia [Hemoglobin < 8], other acute medical conditions such as respiratory infection and pyrexia may disqualify participants, recognized genetic mutations may disqualify patients