Alzheimer DementiaPhase 2NCT02833792
Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease
A Phase 2 study testing Human Mesenchymal Stem Cells and Lactated Riunger's Solution in people with Alzheimer Dementia, run by Stemedica Cell Technologies, Inc. at 1 site in United States.
Trial summary
STUDY OBJECTIVES Primary: To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects with mild to moderate dementia due to Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer Dementia
- What is being tested?
- Human Mesenchymal Stem Cells and Lactated Riunger's Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 31 Dec 2024
- Phase
- Phase 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between 55-80 years of age.
- Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative
- Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.
- MMSE between 12-24 (inclusive) at time of enrollment.
- Amyloid-positive florbetapir PET scan.
Who cannot join
- Prior treatment with stem cells.
- History of intracranial, subdural, or subarachnoid hemorrhage.
- Subjects with baseline brain MRI showing more than four (4) cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), and/or one (1) or more areas of superficial siderosis, and/or evidence of a prior macrohemorrhage. MRI must include fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
- History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
- History of seizure disorder.
- Diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
- History of cerebral neoplasm.
- Myocardial infarction within six months of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
John Wayne Cancer Institute @ Providence St. John's Health Center
Santa Monica, California, 90404
Mini Gill, RN BSN, 310-582-7437, Jaya.Gill@providence.org
Santosh Kesari, MD, PhD
About this study
Official title: A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer's Disease
STUDY OBJECTIVES
Primary:
To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects with mild to moderate dementia due to Alzheimer's disease.
Secondary:
To assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.
Read the detailed description
This is a Phase IIa multi-center, randomized, single-blind, placebo-controlled, crossover study in subjects with mild to moderate dementia due to Alzheimer's disease. Only the subject and their caregiver will be blinded to the study treatment. The study will consist of two cohorts of subjects (20 subjects per cohort), randomized in a 1:1 allocation to receive active study drug or placebo. Cohort 1 will receive a single intravenous dose of hMSCs of 1.5 million cells per kilogram body weight on their Study Day 1, and Cohort 2 will receive equal volume of Lactated Ringer's Solution on their Study Day 1. At the six-month time point for each subject after their first infusion, Cohort 1 will receive a single intravenous dose of Lactated Ringer's Solution and Cohort 2 will receive a single intravenous dose of hMSCs at 1.5 million cells per kilogram of the subject's body weight. Approximately 40 subjects will be enrolled in this study. An independent Data and Safety Monitoring Board will conduct periodic safety reviews.
- Conditions
- Alzheimer Dementia
- Being tested
- Human Mesenchymal Stem Cells and Lactated Riunger's Solution, 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.
Human Mesenchymal Stem Cells and Lactated Riunger's SolutionDrug
Intravenous administration
PlaceboOther
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Stem Cells | Experimental | Stem cells Receives: Drug: Human Mesenchymal Stem Cells and Lactated Riunger's Solution |
| Placebo | Placebo comparator | Lactated Ringer's Solution Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of aMBMC administration
Number of patients with adverse events will be reported
Measured: 18 months
Secondary outcomes (1)
Efficacy of aMBMC administration
Changes is scores relatively to baseline using NIHSS system will be reported for each patient
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemedica Cell Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stemedica International SA
- Responsible party
- Sponsor
- Investigators
- Lev Verkh, PhD, Study chair, Stemedica Cell Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833792
- Sponsor's protocol ID
- STEM105-M-AD
- Status last verified
- Oct 2020
- First submitted
- 20 Jun 2016
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects With Mild to Moderate Dementia Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02833792
- Acronym / sponsor ID
- STEM105-M-AD
- Conditions
- Alzheimer Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stemedica Cell Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stemedica International SA
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Jul 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.
STUDY OBJECTIVES
Primary:
To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects with mild to moderate dementia due to Alzheimer's disease.
Secondary:
To assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.
Detailed description
This is a Phase IIa multi-center, randomized, single-blind, placebo-controlled, crossover study in subjects with mild to moderate dementia due to Alzheimer's disease. Only the subject and their caregiver will be blinded to the study treatment. The study will consist of two cohorts of subjects (20 subjects per cohort), randomized in a 1:1 allocation to receive active study drug or placebo. Cohort 1 will receive a single intravenous dose of hMSCs of 1.5 million cells per kilogram body weight on their Study Day 1, and Cohort 2 will receive equal volume of Lactated Ringer's Solution on their Study Day 1. At the six-month time point for each subject after their first infusion, Cohort 1 will receive a single intravenous dose of Lactated Ringer's Solution and Cohort 2 will receive a single intravenous dose of hMSCs at 1.5 million cells per kilogram of the subject's body weight. Approximately 40 subjects will be enrolled in this study. An independent Data and Safety Monitoring Board will conduct periodic safety reviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem Cells | Experimental | Drug: Human Mesenchymal Stem Cells and Lactated Riunger's SolutionStem cells |
| Placebo | Placebo comparator | Other: PlaceboLactated Ringer's Solution |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females between 55-80 years of age.
- Diagnosed with mild to moderate dementia for at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative
- Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINDS-ADRDA) Alzheimer's criteria.
- MMSE between 12-24 (inclusive) at time of enrollment.
- Amyloid-positive florbetapir PET scan.
Key exclusion criteria (8 listed)
- Prior treatment with stem cells.
- History of intracranial, subdural, or subarachnoid hemorrhage.
- Subjects with baseline brain MRI showing more than four (4) cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), and/or one (1) or more areas of superficial siderosis, and/or evidence of a prior macrohemorrhage. MRI must include fluid-attenuation inversion recovery (FLAIR) and T2*-weighted gradient-recalled-echo (GRE) sequences.
- History of cancer within the past 5 years, with the exception of localized basal or squamous cell carcinoma.
- History of seizure disorder.
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 |
|---|---|---|
| Human Mesenchymal Stem Cells and Lactated Riunger's SolutionIntravenous administration | Drug | Stem Cells |
| PlaceboIntravenous administration | Other | Placebo |
Primary outcome
Safety of aMBMC administration
Time frame: 18 months
Number of patients with adverse events will be reported
1 secondary outcome
Efficacy of aMBMC administration
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Sponsor informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lev Verkh, PhD study chair
Stemedica Cell Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Mesenchymal Stem Cells and Lactated Riunger's Solution in people with Alzheimer Dementia, run by Stemedica Cell Technologies, Inc. at 1 site 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 5 inclusion and 8 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 28 Oct 2022. 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 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 phase mean?
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?
Contact Lev Verkh, PhD (858-658-0910, lverkh@stemedica.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of aMBMC administration (time frame: 18 months). 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 28 Oct 2022.