Alzheimers disease Alzheimers disease
Conditions
Interventions
The cultured autologous adipose-derived mesenchymal stem cells are intravenously injected into the patient once every 2 weeks, 10 times. (2X10^8cells/dose)
Sponsors
Kudou Chiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Subject is a male or female between the age of 65 and 85. 2)Subject with mild to moderate Alzheimer's disease who satisfies the Mini Mental State Examination 3)Subject with probable Alzheimer's disease who satisfies the International Classification Disease (ICD-10) Code of F00. 4)Subject is taking no medication or a stable dose of a same drug over 3 months for Alzheimer's disease before the screening. 5)One or more caregivers, who can read and speak Japanese, must live with a patient, or provide on average 2 hours of supervision or direct assistance per day. 6)Subject has no active infection. 7)Subject can provide a written informed consent by a patient and family member/legal representative. 8)Subject can be collected an enough amount of adipose tissue. 9)Subject can visit the clinic at regularly scheduled times.
Exclusion criteria
Exclusion criteria: 1)Female subject is pregnant or of childbearing potential who refuse to use a medically acceptable form of conception throughout this study. 2)Subject has signs of delirium. 3)Subject has a severe diabetes (HbA1c 8.0% or more: target blood glucose level of older patient with diabetes and moderate cognitive impairment), severe heart failure (NYHA Class 3 or 4), or severe renal failure (Creatinine clearance <30ml/min). 4)Subject has severe organ disorder (Brain, Lungs, Heart, Liver, Kidneys). (Brain) Subject who admit a history of symptomatic stroke and cerebral hemorrhage within six months prior to treatment. (Lungs) SpO2 93% under (Heart) NYHA Class 3 or 4 (Liver) Child Pugh Class B or C (Kidneys) Subject with CKD severity classification to Red zone in Clinical Practice Guidebook for Chronic kidney disease-2012 (Japanese Society of Nephrology) 5)Subject has uncontrolled hypertension or arrhythmia. 6)Subject has proliferative diabetic retinopathy or age-related macular degeneration. 7)Subject has malignant tumor. If a patient has a complete remission by Surgery or Medication, the patient can enter this study without recurrent tumor in the last 5 years. 8)Subject has any other cause of dementia or a different type of dementia other than Alzheimer's disease. 9)Subject shows abnormal values in the screening tests and may not complete this study judged by the principal investigator. 10)Subject participated in other clinical studies of drugs, stem cells or medical devices within last 3 months prior to the informed consent. 11)Subject has any other psychiatric illness other than Alzheimer's disease that in the opinion of the principal investigator would pose a safety risk or interfere with the appropriate interpretation of study data. 12)Subject is positive for AIDS (Acquired Immunodeficiency Syndrome), HBV (Hepatitis B Virus), HCV (Hepatitis C), VDRL (Venereal Disease Research Laboratory), HTLV (Human T-cell leukemia virus) within 12 weeks prior to the screening. 13)Subject is excessively sensitive to a fetal bovine serum or Penicillin. 14)Subject is taking Aspirin (Acetylsalicylic acid), Ticlid (Ticlopidine), Plavix (Clopidogrel) or Effient (Prasugrel). If a patient can stop these medication during the fat collection, a patient may enter this study. 15)Subject is chronically taking oral corticosteroids, immunosuppressants or any other steroidal anti-inflammatory drugs (e.g. Prednisolone), except for steroid nasal sprays, topical steroids and ovarian hormones prior to the informed consent. 16)Subject has a history of allergy to local anesthetic drugs. 17)Subject is taking anticoagulant: Warfarin potassium, Pradaxa (Dabigatran etexilate), Lixiana (Edoxaban), Xarelto (Rivaroxaban), Eliquis (Apixaban) and so on. 18)Subject is implanted a medical foreign body at a high risk of infection. 19)Subject is considered to be ineligible for this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Frequency of adverse events, Follow-up of adverse events - ADAS-Jcog(Alzheimer's Disease Assessment Scale-cognitive component Japanese version) | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE, ADL behavior Cognition Dimential Scale | — |
Countries
Japan
Contacts
Public ContactMayu Ishikura
Medical Corporation Kudoh Chiaki Neurosurgery Clinic
Outcome results
None listed