cerebral and spinal nerve diseases
Conditions
Interventions
Using an 21G to 23G lumbar needle, stem cell clusters generated from 10 million or 100 million autologous adipose tissue-derived stem cells are administered into the spinal cord cavity.In addition, in
Sponsors
Yuji Hayashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with stroke, Parkinson's disease, Alzheimer's disease, spinal cord in jury, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP), traumatic brain injury (TBI), multiple sclerosis (MS), or other cerebral and spinal nerve diseases. 2) Patients between the ages of 15 and 100 years on the date consent is obtained (regardless of gender). 3) Patients who can adequately assess pain from the screening start date until the end of the 48th week of observation. 4) Patients who have received a thorough explanation using an explanatory document, understand the content of the explanation, and have given written consent to participate in the clinical research based on their free will. 5) Patients who are able to follow the prescribed schedule of visits until the end of the 48week post-treatment examination period.
Exclusion criteria
Exclusion criteria: 1) Patients with skin disease or infection in the abdomen or administration site on the screening test date or administration date and who are at risk of infection by injection etc. 2)Patients who have undergone back surgery in the past 3)Patients who have received physical therapy (exercise therapy physical therapy orthotics, etc.)for the treatment of the underlying disease within 28 days prior to the screening start date (patients who have continuously practiced such therapy for 29 days or more prior to the screening start date may continue to receive it.) 4) Patients with a history of malignancy (with in 5 years prior to obtaining consentor complic)ations. However patients with a history of malignancy within 5 years prior to obtaining consent may be eligible if it is determined to have been cured by surgical procedures or local treatment. 5)Patients with the following symptoms or diseases that may affect the results. Complications of neoplastic disease or serious infection. Patients whose progression is too rapid to be expected to benefit from regeneration 6)Patients on antiplatelet or anticoagulant drugs. 7)Patients with a history or complications of drug addiction or alcoholism. 8)Patients with spinal stenosis proximal to the injection site. 9)Other patients deemed inappropriate by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Cell Mass Administration by Cell Count for cerebral and spinal nerve diseases. <Safety endpoints Evaluate side effects and adverse events such as infection, bleeding, anaphylaxis, and abnormal laboratory values | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of cell mass administration by cell count for cerebral and spinal nerve diseases. Physiological function test Assessment of Neurodegenerative Disease VAS (Visual Analogue Scale) | — |
Countries
Japan
Contacts
Public ContactIshihara Mamoru
Clinic Nagoya Chikusahills
Outcome results
None listed