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This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease. Following first screening period, subjects will be randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1 ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AstroStem | Experimental |
| |
| Placebo-Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AstroStem | Drug | Autologous adipose tissue derived mesenchymal stem cells (AdMSC) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Related Adverse Events | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results | 30 Weeks |
| ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive Subscale) | Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from Baseline at Week 30 Score range: 0-70 A score of 70 represents the most severe impairment and 0 represents the least impairment | Baseline and 30 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MMSE (Mini-mental Status Examination) | Change of MMSE from baseline at Week 30 Score range: 0-30 A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia. | Baseline and 30 Weeks |
| CDR-SOB (Clinical Dementia Rating-Sum of Boxes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research | Costa Mesa | California | 92626 | United States | ||
| Syrentis Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | AstroStem | AstroStem: Autologous adipose tissue derived mesenchymal stem cells (AdMSC) 2x10e8 cells |
| FG001 | Placebo-Control | Saline with 30% auto-serum |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AstroStem | AstroStem: Autologous adipose tissue derived mesenchymal stem cells (AdMSC) |
| BG001 | Placebo-Control | Placebo-Control: Saline with 30% auto-serum |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Related Adverse Events | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results | Posted | Count of Participants | Participants | 30 Weeks |
|
52 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AstroStem | AstroStem: Autologous adipose tissue derived mesenchymal stem cells (AdMSC) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| oesophageal squamous cell carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Open Angle Glaucoma | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Nature Cell co., ltd | 02-545-4137 | tin50@stemcellbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2019 | Jun 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2019 | Jun 17, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 26, 2017 | Jun 17, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo-Control |
| Other |
Saline with 30% auto-serum |
|
Changes of CDR-SOB from baseline at Week 30 Score range: 0-18.0 0 = normal, 0.5-4.0 = questionable cognitive dementia, 4.5-9.0 = mild dementia, 9.5-15.5 = moderate dementia, and 16.0-18.0 = severe dementia |
| Baseline and 30 Weeks |
| NPI (Neuropsychiatric Inventory) | Changes of NPI from baseline at Week 30 Score range: 0-144 higher score indicates higher disturbance. | Baseline and 30 Weeks |
| GDS (Geriatric Depression Scale) | Changes of GDS from baseline at Week 30 Score range: 0-15 Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. | Baseline and 30 Weeks |
| ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) | Change of ADCS-ADL from baseline at Week 30 Score range: 0-78 Lower score indicates greater severity. | Baseline and 30 Weeks |
| C-SSRS (Columbia Suicide Severity Rating Scale) | Changes of C-SSRS from baseline at Week 30 Score range: 0-25 Higher score indicates higher severity. | Baseline and 30 Weeks |
| Santa Ana |
| California |
| 92705 |
| United States |
| Valden Medical | Honolulu | Hawaii | 96817 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive Subscale) | Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from Baseline at Week 30 Score range: 0-70 A score of 70 represents the most severe impairment and 0 represents the least impairment | 3 of the 11 astrostem groups were dropped out and 1 was violated protocol. 1 of the 10 Placebo-control groups was dropped out and 2 were violated protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30 Weeks |
|
|
|
| Secondary | MMSE (Mini-mental Status Examination) | Change of MMSE from baseline at Week 30 Score range: 0-30 A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia. | 3 of the 11 astrostem groups were dropped out and 1 was violated protocol. 1 of the 10 Placebo-control groups was dropped out and 2 were violated protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30 Weeks |
|
|
|
| Secondary | CDR-SOB (Clinical Dementia Rating-Sum of Boxes) | Changes of CDR-SOB from baseline at Week 30 Score range: 0-18.0 0 = normal, 0.5-4.0 = questionable cognitive dementia, 4.5-9.0 = mild dementia, 9.5-15.5 = moderate dementia, and 16.0-18.0 = severe dementia | 3 of the 11 astrostem groups were dropped out and 1 was violated protocol. 1 of the 10 Placebo-control groups was dropped out and 2 were violated protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30 Weeks |
|
|
|
| Secondary | NPI (Neuropsychiatric Inventory) | Changes of NPI from baseline at Week 30 Score range: 0-144 higher score indicates higher disturbance. | 3 of the 11 astrostem groups were dropped out and 1 was violated protocol. 1 of the 10 Placebo-control groups was dropped out and 2 were violated protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30 Weeks |
|
|
|
| Secondary | GDS (Geriatric Depression Scale) | Changes of GDS from baseline at Week 30 Score range: 0-15 Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression. | 3 of the 11 astrostem groups were dropped out and 1 was violated protocol. 1 of the 10 Placebo-control groups was dropped out and 2 were violated protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30 Weeks |
|
|
|
| Secondary | ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) | Change of ADCS-ADL from baseline at Week 30 Score range: 0-78 Lower score indicates greater severity. | 3 of the 11 astrostem groups were dropped out and 1 was violated protocol. 1 of the 10 Placebo-control groups was dropped out and 2 were violated protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30 Weeks |
|
|
|
| Secondary | C-SSRS (Columbia Suicide Severity Rating Scale) | Changes of C-SSRS from baseline at Week 30 Score range: 0-25 Higher score indicates higher severity. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 30 Weeks |
|
|
|
| 0 |
| 11 |
| 3 |
| 11 |
| 3 |
| 11 |
| EG001 | Placebo-Control | Placebo-Control: Saline with 30% auto-serum | 0 | 10 | 1 | 10 | 2 | 10 |
|
| diarrhea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Acute Pulmonary Oedema | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrointestinal Reflux Disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Infusion Site Reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abnormal Loss of Weight | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |