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IRCT20240131060870N1 IRCT 2024-02-19 Iran University of Medical Sciences Investigating the Effect of Intranasal Spray Containing Conditioned Medium from Umbilical Cord in Alzheimer's Disease Safety of Intranasal Spray Containing the Conditioned Medium of Mesenchymal Stem Cells Derived from Umbilical Cord Wharton's jelly in Alzheimer's Disease (Mild to Moderate) in phase 1 of a clinical trial 2024-04-15 anticipated 9 Complete https://irct.ir/trial/75444 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: Convenience Sampling. 1 Mild to moderate phase ,Alzheimer's patients, Alzheimer Disease, AD, Dementia. Intervention 1: Intervention group:: First, conditioned media solution or conditioned medium derived from mesenchymal stem cells from Wharton's jelly umbilical cord, 1 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days, produced in the hospital Motahari, Iran University of Medical Sciences. Intervention 2: Intervention group: Second, CM, 2 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days,. Intervention 3: Intervention group: Third, CM, 3 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days,. Yes - There is a plan to make this available What will be shared: . When: . To whom: . Conditions: . Where to obtain: . How to obtain: . Comments: .
public Naser Amini
Cellular and Molecular Research Center Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1636743943 +98 21 8670 4720 amini.n@iums.ac.ir Iran University of Medical Sciences scientific Naser Amini
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, School of Advanced Technologies in Medicine, Cellular and Molecular Research Center
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4837 amini.n@iums.ac.i Iran University of Medical Sciences Iran (Islamic Republic of) Patients who have brain structural changes based on MRI and doctor's diagnosis, which confirms their Alzheimer's dementia. Gender and Age: men and women between 60 and 85 Y. Diagnosis of Mild to Moderate Alzheimer's dementia at least 6 months before the start of the study. MMSE (Mini-Mental State Examination) Score: 10 and 24 at the time of starting the study 60 years 85 years Both Cancer patients who have been diagnosed in the last 5 years. Patients who cannot undergo MRI due to their condition. People with mental disorders Have diseases such as vitamin B12 deficiency, diabetes, hypo/hyperthyroidism, and hepatitis. History of cell therapy in the last 6 months. Subjects who have participated in another clinical study within 3 months before the start of this study. History of brain neoplasm. G30.1 Diseases, Nervous System, Degenerative, Alzheimer's Disease, Late-onset, After the age of 65, AD, Dementia, Neurodegenerative, Central nervous system, CNS Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group:: First, conditioned media solution or conditioned medium derived from mesenchymal stem cells from Wharton's jelly umbilical cord, 1 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days, produced in the hospital Motahari, Iran University of Medical Sciences Intervention group: Second, CM, 2 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days, Intervention group: Third, CM, 3 cc as an intranasal spray, twice a day (every 12 hours), for 3 consecutive days, Fever. Timepoint: Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy. Method of measurement: Thermometer. Headache. Timepoint: Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy. Method of measurement: Visual Analogue Scale (VAS). Dizziness, Nausea, and Vomiting. Timepoint: Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy. Method of measurement: Dizziness Questionnaire: is a 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. Item scores are summed. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. Pro-inflammatory cytokines: IL-1β, TNF-α and IL-6. Timepoint: Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy. Method of measurement: Human interleukin ELISA kit: designed for quantitative measurement of β1, IL-6 and TNF alpha in serum, plasma, cerebrospinal fluid and cell culture supernatant samples. This kit is designed and produced using monoclonal antibodies against human interleukins. Therefore, it is not used in measuring similar animal cases. Growth Factors:GF:TGF-β and BDNF. Timepoint: Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy. Method of measurement: ELISA kit Human TGF-B and BDNF: designed to detect TGF-β and BDNF in tissue samples, serum, plasma, cerebrospinal fluid and human cell culture supernatant. Protein Amyloid beta (Aβ). Timepoint: Days 0, 1,2,3,4 and 2 weeks after CM (Conditioned Medium ) therapy. Method of measurement: Blood Sample: Measurement of beta-amyloid plasma level by blood test. The instrumental Activities of Daily Living Scale (IADL) is used to assess a patient's independent living skills and measures. Timepoint: 0 ,2 week,1 and 3 month after CM therapy. Method of measurement: IADL Paper Questionnaire: which has 18 points. Montreal Cognitive Assessment Test (MOCA): was designed as a rapid screening tool for "mild cognitive impairment" and "Alzheimer's disease". Timepoint: 0 ,2 week,1 and 3 month after CM therapy. Method of measurement: MOCA Paper Questionnaire: It is used to measure different levels of memory and the person must have at least 6 classes of literacy. Questionnaire ADL (Activities of Daily Living Scale) is a tool designed to measure the level of independence in ADLs in clinical outpatient populations. Timepoint: 0 ,2 week,1 and 3 month after CM therapy. Method of measurement: Questionnaire ADL is paper-based and has 14 points. Deputy of research and technology, Iran University of Medical Sciences and Health Services Approved 2024-01-06 Ethics Committee of Iran University of Medical Sciences Ethics Committee in Biomedical Research, Ethics in Research Working Group, Research and Technology Vice President, Central Headquarters Building, Iran University of Medical Sciences, Tehran Tehran Tehran Iran (Islamic Republic of)