Alzheimer's DiseasePhase 1/2NCT02912169
Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells in Patients With Alzheimer's Disease
A Phase 1/2 study testing Liposuction under local anesthesia and Infusion of AD-SVF via IV and Intranasal in people with Alzheimer's Disease, run by Ageless Regenerative Institute at 1 site in United States.
Trial summary
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with Alzheimer's Disease and clinical outcomes? Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Liposuction under local anesthesia and Infusion of AD-SVF via IV and Intranasal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 15 Nov 2017
- 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, age 55 or older
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Up to date on all age and gender appropriate cancer screening per American Cancer Society (Refer to section 9.3 for more details).
Who cannot join
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease. For patients who have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis ,then an expert will be consulted as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
- Patients on chronic immunosuppressive transplant therapy
Show all 14Show fewer
- Systolic blood pressure (supine) ≤90 mmHg;
- Resting heart rate > 100 bpm;
- Active clinical infection.
- Cerebrovascular accident within 6 months prior to study entry
- Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
- History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
- Patient or legal guardian if applicable us unwilling and/or not able to give written informed consent.
- Dementia due to any condition other than AD, including vascular dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Ageless Regenerative Institute LLC
Aventura, Florida, 33180
About this study
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Vascular Fraction (AD-SVF) Cells Delivered Intravenous (IV) and Intranasal in Patients With Alzheimer's Disease
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with Alzheimer's Disease and clinical outcomes?
Read the detailed description
Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF) will be infused intra-venous and Intra nasal. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
- Conditions
- Alzheimer's Disease
- Being tested
- Liposuction under local anesthesia, Infusion of AD-SVF via IV and Intranasal
- Keywords
- Alzheimer's Disease, Alzheimer's, Stem cell, Adipose-derived stem cells, ASC, ADSC
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposuction under local anesthesiaProcedure or surgery
Also called Lipoaspiration, Adipose tissue harvesting
Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.
Infusion of AD-SVF via IV and IntranasalBiological
IV and Intranasal Infusion of isolated AD-SVF
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose-derived Stromal Vascular Fraction infusion | Experimental | Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal. Receives: Procedure: Liposuction under local anesthesia; Biological: Infusion of AD-SVF via IV and Intranasal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Improvement in Mini Mental State Examination (MMSE)
Improvement in MMSE six months after therapy
Measured: Six months after therapy
Secondary outcomes (5)
Adverse Event
The safety of adipose-derived stem cell injection will be evaluated by assessment of the frequency and nature of adverse events occurring during the study injection and up to the 12-months period following treatment.
Measured: One year after stem cell therapy
Clinical Improvement in Functional Activities Questionnaire (FAQ)
Measured: Three and six months after therapy
Clinical Improvement in Activities of Daily Living Questionnaire (ADL)
Measured: Three and six months after therapy
Clinical Improvement in Geriatric Depression Scale (GDS)
Measured: Three and six months after therapy
Clinical Improvement in Mini Mental State Examination (MMSE)
Measured: Three months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study start1 Nov 2015
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Why it stopped: company dissolved
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon McQuillan, MD, Principal investigator, Ageless Regenerative Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912169
- Sponsor's protocol ID
- AD-US-ALZ-001
- Status last verified
- Nov 2017
- First submitted
- 6 Apr 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Vascular Fraction (AD-SVF) Cells Delivered Intravenous (IV) and Intranasal in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02912169
- Acronym / sponsor ID
- AD-US-ALZ-001
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Alzheimer's, Stem cell, Adipose-derived stem cells, ASC, ADSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: company dissolved
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 23 Sep 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 intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with Alzheimer's Disease and clinical outcomes?
Detailed description
Autologous Adipose-derived Stromal Vascular Fraction (AD-SVF) will be infused intra-venous and Intra nasal. The therapy is composed of cells derived from a patients' own adipose tissue that are isolated within approximately 1 hour and immediately delivered back to the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose-derived Stromal Vascular Fraction infusion | Experimental | Procedure: Liposuction under local anesthesia, Biological: Infusion of AD-SVF via IV and IntranasalAutologous Adipose-derived Stromal Vascular Fraction (AD-SVF infusion) intravenous (IV) and Intranasal. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females, age 55 or older
- Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and 2) Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Up to date on all age and gender appropriate cancer screening per American Cancer Society (Refer to section 9.3 for more details).
Key exclusion criteria (14 listed)
- Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
- Life expectancy < 6 months due to concomitant illnesses.
- Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- Active infectious disease. For patients who have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis ,then an expert will be consulted as to patient eligibility based on the patient's infectious status
- Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
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 |
|---|---|---|
| Liposuction under local anesthesiaAlso: Lipoaspiration, Adipose tissue harvestingProcedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells. | Procedure or surgery | Autologous Adipose-derived Stromal Vascular Fraction infusion |
| Infusion of AD-SVF via IV and IntranasalIV and Intranasal Infusion of isolated AD-SVF | Biological | Autologous Adipose-derived Stromal Vascular Fraction infusion |
Primary outcome
Clinical Improvement in Mini Mental State Examination (MMSE)
Time frame: Six months after therapy
Improvement in MMSE six months after therapy
5 secondary outcomes
Adverse Event
Time frame: One year after stem cell therapy
Clinical Improvement in Functional Activities Questionnaire (FAQ)
Time frame: Three and six months after therapy
Clinical Improvement in Activities of Daily Living Questionnaire (ADL)
Time frame: Three and six months after therapy
Clinical Improvement in Geriatric Depression Scale (GDS)
Time frame: Three and six months after therapy
Clinical Improvement in Mini Mental State Examination (MMSE)
Time frame: Three months after therapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Sharon McQuillan, MD principal investigator
Ageless Regenerative Institute
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 Liposuction under local anesthesia and Infusion of AD-SVF via IV and Intranasal in people with Alzheimer's Disease, run by Ageless Regenerative Institute 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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 24 Nov 2017. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical Improvement in Mini Mental State Examination (MMSE) (time frame: Six months after therapy). 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 24 Nov 2017.