Alzheimer's DiseasePhase 1/2SEESUPADNCT02672306
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Alzheimer's Disease
A Phase 1/2 study testing UCMSCs in people with Alzheimer's Disease, run by South China Research Center for Stem Cell and Regenerative Medicine at 1 site in China.
Trial summary
The primary purpose of this study is to evaluate the safety and the efficacy of (Human Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- UCMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2017to Oct 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 50 to 80, male and female.
- A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- Treatment with other cholinesterase inhibitors, such as a stable dose of donnepiazide tablets (5mg/ day or 10mg/ day) or the use of heavy tartaric acid karbalin capsules, is currently being used.
- MMSE score between 10 and 26.
- Voluntarily participating subject who sign the Inform Concent
Who cannot join
- Caused by other reasons of dementia (vascular dementia, infectious disease of the central nervous system (such as HIV, syphilitic dementia), g - she's disease, Parkinson's disease, Lou gehrig's disease, huntington's disease DLB, traumatic brain dementia, other physical and chemical factors (such as: drug poisoning, alcoholism, carbon monoxide poisoning and other dementia), important body disease (such as hepatic encephalopathy, pulmonary encephalopathy dementia), intracranial placeholder lesions, endocrine system disease, such as thyroid disease, parathyroid disease), and vitamins and other causes of dementia)
- The Hamilton depression scale (HAMD) score > 17, or patients with a history of depression or other psychiatric or psychiatric disorders.
- The Hachinski ischemic index scale (HIS) scored > 4.
- The brief intelligence status examination scale (MMSE) score of 10 patients.
- Liver function (ALT, AST) exceeded the normal range limit of 1.5 times, SCr exceeded normal range upper limit, white blood cell count < 4.0 x 109/L or platelet < 100 x 109/L, hemoglobin < 100g/L.
- Patients with type 1 diabetes, obstructive pulmonary disease (copd) or asthma, vitamin B12 or folate deficiency patients, not control good digestion, liver, kidney, endocrine and cardiovascular system diseases (especially sick sinus syndrome and conduction block), patients with HIV/AIDS, syphilis, active tuberculosis, etc.
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- A person with cancer or a history of cancer.
- People with a clinically significant history of stroke, who have had a seizure or a head injury in the past two years, have caused the disorder.
- There is a history of congestive heart failure or a history of myocardial infarction, and a blood disease in two years.
- Drug clinical trials were performed within 3 months of screening.
- Anti-ad agents are being used in addition to the programme requirements.
- The use of stem cell therapy in half a year.
- People with history of alcoholism and substance abuse, allergies, or history of allergies.
- Patients who had been hospitalized for more than 3 months before screening. of allergies.
- The researchers think it is inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
South China Research Center for Stem Cell and Regenerative Medicine,South China Institute of Biomedicine
Guangzhou, Guangdong, 510320
About this study
Official title: Clinical Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Mild and Moderate Alzheimer's Disease
The primary purpose of this study is to evaluate the safety and the efficacy of (Human Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease (AD).
Read the detailed description
Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Randomized, Safety/ Efficacy Study Official Title: Multicenter, Randomized, Double-blind, Placebo Controlled Trial of UCMSCs in Subjects With Alzheimer's Disease
- Conditions
- Alzheimer's Disease
- Being tested
- UCMSCs, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCMSCsBiological
Also called Human Umbilical Cord Derived Mesenchymal
Biological: Human UCMSCs 20 million cells per subject (0.5×10^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks)
PlaceboBiological
Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)
| Study group | Role | What they receive |
|---|---|---|
| UCMSCs | Experimental | Subjects with Alzheimer's Disease Intervention: UCMSCs Receives: Biological: UCMSCs |
| Placebo | Placebo comparator | Subjects with Alzheimer's Disease Intervention: Placebo (normal saline) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
Measured: 36 weeks from post-administration
Secondary outcomes (6)
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
Measured: 10 weeks,18 weeks,24 weeks,48weeks from post-administration
Change in Mini-Mental State Examination (MMSE) Score
A frequently used screening instrument for Alzheimer's disease drug studies. It evaluates orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons.
Measured: 10 weeks,18 weeks,36 weeks，24 weeks,48weeks from post-administration
Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score
Measured: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score
ADCS-ADL assesses functional performance in subjects with Alzheimer's disease. In a structured interview format, informants are queried as to whether subjects attempted each item in the inventory during the prior 4 weeks and their level of performance. The ADCS-ADL scale discriminates well between normal controls and mild AD patients. It has good test-retest reliability. The ADCS-ADL includes some items from traditional basic ADL scales (e.g., grooming, dressing, walking, bathing, feeding, toileting) as well as items from instrumental activities of daily living scales (e.g., shopping, preparing meals, using household appliances, keeping appointments, reading).
Measured: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Change in Neuropsychiatric Inventory (NPI) Score
The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology and behavior in AD based on interview with the informant.
Measured: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Changes in AD Biomarkers
Plasma beta-amyloid proteins will be collected from blood samples obtained.
Measured: 36 weeks from post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start20 Oct 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou General Hospital of Guangzhou Military Command, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672306
- Sponsor's protocol ID
- UCMSC-1
- Acronym
- SEESUPAD
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Mild and Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02672306
- Acronym / sponsor ID
- SEESUPAD / UCMSC-1
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- South China Research Center for Stem Cell and Regenerative MedicineUniversity, hospital or other
- Collaborators
- Guangzhou General Hospital of Guangzhou Military Command, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety and the efficacy of (Human Umbilical Cord-Derived Mesenchymal Stem Cells) UCMSCs for patients with Alzheimer's disease (AD).
Detailed description
Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Randomized, Safety/ Efficacy Study Official Title: Multicenter, Randomized, Double-blind, Placebo Controlled Trial of UCMSCs in Subjects With Alzheimer's Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSCs | Experimental | Biological: UCMSCsSubjects with Alzheimer's Disease Intervention: UCMSCs |
| Placebo | Placebo comparator | Biological: PlaceboSubjects with Alzheimer's Disease Intervention: Placebo (normal saline) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages 50 to 80, male and female.
- A diagnosis of probable AD and Mixed Dementia according to the criteria of the NINCDS-ADRDA
- Treatment with other cholinesterase inhibitors, such as a stable dose of donnepiazide tablets (5mg/ day or 10mg/ day) or the use of heavy tartaric acid karbalin capsules, is currently being used.
- MMSE score between 10 and 26.
- Voluntarily participating subject who sign the Inform Concent
Key exclusion criteria (15 listed)
- Caused by other reasons of dementia (vascular dementia, infectious disease of the central nervous system (such as HIV, syphilitic dementia), g - she's disease, Parkinson's disease, Lou gehrig's disease, huntington's disease DLB, traumatic brain dementia, other physical and chemical factors (such as: drug poisoning, alcoholism, carbon monoxide poisoning and other dementia), important body disease (such as hepatic encephalopathy, pulmonary encephalopathy dementia), intracranial placeholder lesions, endocrine system disease, such as thyroid disease, parathyroid disease), and vitamins and other causes of dementia)
- The Hamilton depression scale (HAMD) score > 17, or patients with a history of depression or other psychiatric or psychiatric disorders.
- The Hachinski ischemic index scale (HIS) scored > 4.
- The brief intelligence status examination scale (MMSE) score of 10 patients.
- Liver function (ALT, AST) exceeded the normal range limit of 1.5 times, SCr exceeded normal range upper limit, white blood cell count < 4.0 x 109/L or platelet < 100 x 109/L, hemoglobin < 100g/L.
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 |
|---|---|---|
| UCMSCsAlso: Human Umbilical Cord Derived MesenchymalBiological: Human UCMSCs 20 million cells per subject (0.5×10^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks) | Biological | UCMSCs |
| PlaceboSubjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks) | Biological | Placebo |
Primary outcome
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
Time frame: 36 weeks from post-administration
A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis.
6 secondary outcomes
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score
Time frame: 10 weeks,18 weeks,24 weeks,48weeks from post-administration
Change in Mini-Mental State Examination (MMSE) Score
Time frame: 10 weeks,18 weeks,36 weeks，24 weeks,48weeks from post-administration
Change in Clinician's Interview-Based Impression of Change (CIBIC-plus) Score
Time frame: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) Score
Time frame: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Change in Neuropsychiatric Inventory (NPI) Score
Time frame: 10 weeks,18 weeks,24 weeks,36 weeks，48weeks from post-administration
Changes in AD Biomarkers
Time frame: 36 weeks from post-administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Individual participant dataSharing planned: Yes
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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.
1 site 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 UCMSCs in people with Alzheimer's Disease, run by South China Research Center for Stem Cell and Regenerative Medicine at 1 site in China.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
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?
Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)Score (time frame: 36 weeks from post-administration). 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 26 Apr 2018.