Alzheimer DiseasePhase 1/2NCT03117738
A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease
A Phase 1/2 study testing AstroStem in people with Alzheimer Disease, run by Nature Cell Co. Ltd. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- AstroStem
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 May 2017to 31 Aug 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged 50 and above at the time of signing the Informed Consent form
- Subjects who can understand and provide written informed consent (assent)
- Subjects who have diagnosis of probable mild-to-moderate Alzheimer disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association) criteria
- Subjects who have MMSE Score of 16 to 26 at screening
- Subjects who are taking FDA-approved AD medications (donepezil, galantamine, memantine, rivastigmine or their combinations) treatment on a stable dosage for at least 3 months prior to screening.
- Subjects who have one (or more) identified adult caregiver who is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥4 days/week; and agrees to accompany the subject to each study visit
- Subjects who have a designated study partner who will accompany the subject to all clinic visits and participate in the subject's clinical assessments
Who cannot join
- Subjects who are females who are pregnant, nursing, or of childbearing potential while not practicing effective contraception
- Subjects who have signs of delirium
- Subjects who have had cortical stroke within the preceding 2 years
- Subjects who have a prolonged QTc interval; >450 msec in male or >470 msec in female at screening
- Subjects who have diagnosis of severe white matter hyperintensity (WMH), which is defined as ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths
- Subjects who have diagnosis of dementia or cause of cognitive impairment other than Alzheimer's disease
Show all 19Show fewer
- Subjects who have a significant abnormal result in laboratory tests, in the opinion of the investigator
- Subjects who have participated in any investigational drug, stem cell therapy, or device trial within the previous 3 months at screening
- Subjects with any current psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the subject´s ability to complete the study
- Subjects who are known to have autosomal dominant mutation-associated presenile AD
- Subjects who show signs of AIDS (Acquired Immunodeficiency Syndrome), HBV (Hepatitis B Virus), HCV (Hepatitis C), VDRL (Venereal Disease Research Laboratory)
- Subjects who have any conditions that would contraindicate an MRI, such as the presence metallic objects in the eyes, skin, or heart
- Subjects who have > 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, or evidence of a prior microhemorrhage as assessed by MRI
- Subjects who have history of malignant cancer within the last 5 years (The following is a partial list of conditions that are permissible for study entry: non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer)
- Subjects who have suspected active lung disease based on chest X-ray
- Subjects who are hypersensitive to fetal bovine serum or penicillin
- Subjects who are currently using immunosuppressants, cytotoxic drug, corticosteroids or similar steroidal anti-inflammatory medication (e.g., Prednisone) on a regular basis (exceptions allowed include; regular use of steroidal nasal sprays, topical steroids, and estrogen-replacement therapy)
- Subjects for whom the investigator judges the liposuction can cause any problems
- Subjects who have history of local anesthetic allergy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
ATP Clinical Research
Costa Mesa, California, 92626
Valden Medical
Honolulu, Hawaii, 96817
Syrentis Clinical Research
Santa Ana, California, 92705
About this study
Official title: A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease
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.
- Conditions
- Alzheimer Disease
- Being tested
- AstroStem, Placebo-Control
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstroStemDrug
Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
Placebo-ControlOther
Saline with 30% auto-serum
| Study group | Role | What they receive |
|---|---|---|
| AstroStem | Experimental | Not described Receives: Drug: AstroStem |
| Placebo-Control | Placebo comparator | Not described Receives: Other: Placebo-Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 30 Weeks
Secondary outcomes (6)
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.
Measured: Baseline and 30 Weeks
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
Measured: Baseline and 30 Weeks
NPI (Neuropsychiatric Inventory)
Changes of NPI from baseline at Week 30 Score range: 0-144 higher score indicates higher disturbance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 30 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start9 May 2017
- Primary completion26 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature Cell Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117738
- Sponsor's protocol ID
- AST-ADP2-US01
- Status last verified
- Jun 2021
- First submitted
- 10 Apr 2017
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03117738
- Acronym / sponsor ID
- AST-ADP2-US01
- Conditions
- Alzheimer Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nature Cell Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AstroStem | Experimental | Drug: AstroStem |
| Placebo-Control | Placebo comparator | Other: Placebo-Control |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects aged 50 and above at the time of signing the Informed Consent form
- Subjects who can understand and provide written informed consent (assent)
- Subjects who have diagnosis of probable mild-to-moderate Alzheimer disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association) criteria
- Subjects who have MMSE Score of 16 to 26 at screening
- Subjects who are taking FDA-approved AD medications (donepezil, galantamine, memantine, rivastigmine or their combinations) treatment on a stable dosage for at least 3 months prior to screening.
Key exclusion criteria (19 listed)
- Subjects who are females who are pregnant, nursing, or of childbearing potential while not practicing effective contraception
- Subjects who have signs of delirium
- Subjects who have had cortical stroke within the preceding 2 years
- Subjects who have a prolonged QTc interval; >450 msec in male or >470 msec in female at screening
- Subjects who have diagnosis of severe white matter hyperintensity (WMH), which is defined as ≥ 25mm of the deep white matter and ≥ 10mm of the periventricular capping/banding in lengths
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AstroStemAutologous adipose tissue derived mesenchymal stem cells (AdMSC) | Drug | AstroStem |
| Placebo-ControlSaline with 30% auto-serum | Other | Placebo-Control |
Primary outcome
Treatment Related Adverse Events
Time frame: 30 Weeks
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
ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive Subscale)
Time frame: Baseline and 30 Weeks
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
6 secondary outcomes
MMSE (Mini-mental Status Examination)
Time frame: Baseline and 30 Weeks
CDR-SOB (Clinical Dementia Rating-Sum of Boxes)
Time frame: Baseline and 30 Weeks
NPI (Neuropsychiatric Inventory)
Time frame: Baseline and 30 Weeks
GDS (Geriatric Depression Scale)
Time frame: Baseline and 30 Weeks
ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living)
Time frame: Baseline and 30 Weeks
C-SSRS (Columbia Suicide Severity Rating Scale)
Time frame: Baseline and 30 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AstroStem in people with Alzheimer Disease, run by Nature Cell Co. Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Related Adverse Events (time frame: 30 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.