Alzheimer DiseaseNCT04855955
Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
A study testing Adipose-Derived Mesenchymal Stem Cells in people with Alzheimer Disease, run by Celltex Therapeutics Corporation.
Trial summary
This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Adipose-Derived Mesenchymal Stem Cells
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- The patient is diagnosed with later stage of Alzheimer Disease with sever cognitive disability.
- All current anti-Alzheimer medicines cannot prevent disease progression and the patient's mental and physical ability persistently declined
- Patient's legal guardian and caregiver must voluntarily sign an approved written consent form after ample explanation of the proposed therapy.
Who cannot join
- Current diagnosis of malignancy
- Renal/liver dysfunction: Exceed two times as normal subject
- Pregnant or nursing
- Received other trial drugs within 30 days after participation of this study
- Experienced major surgery or trauma in the last 14 days
About this study
Official title: Individual Patient Expanded Access Investigation New Drug (IND) Application for Administration of Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life.
- Conditions
- Alzheimer Disease
- Being tested
- Adipose-Derived Mesenchymal Stem Cells
- Keywords
- Autologous Adipose-derived Stem Cells (AdMSCs)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose-Derived Mesenchymal Stem CellsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Celltex Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard L Neel, M.D., Principal investigator, Little Alsace Urgent Care Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855955
- Sponsor's protocol ID
- CTXSP0001
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual Patient Expanded Access Investigation New Drug (IND) Application for Administration of Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04855955
- Acronym / sponsor ID
- CTXSP0001
- Conditions
- Alzheimer Disease
- Keywords
- Autologous Adipose-derived Stem Cells (AdMSCs)
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Celltex Therapeutics CorporationIndustry (pharma, biotech, devices)
- First posted
- 22 Apr 2021 (actual)
- 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.
This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life.
Study design
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is diagnosed with later stage of Alzheimer Disease with sever cognitive disability.
- All current anti-Alzheimer medicines cannot prevent disease progression and the patient's mental and physical ability persistently declined
- Patient's legal guardian and caregiver must voluntarily sign an approved written consent form after ample explanation of the proposed therapy.
Key exclusion criteria (5 listed)
- Current diagnosis of malignancy
- Renal/liver dysfunction: Exceed two times as normal subject
- Pregnant or nursing
- Received other trial drugs within 30 days after participation of this study
- Experienced major surgery or trauma in the last 14 days
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 |
|---|---|---|
| Adipose-Derived Mesenchymal Stem Cells | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Richard L Neel, M.D. principal investigator
Little Alsace Urgent Care Center
Questions about this trial
What is this clinical trial studying?
A study testing Adipose-Derived Mesenchymal Stem Cells in people with Alzheimer Disease, run by Celltex Therapeutics Corporation.
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 5 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 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 7 Feb 2024.