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Enrolling by invitationNCT03724136ACISTUpdated Apr 15, 2024

Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

An interventional study of Intravenous Bone Marrow Stem Cell (BMSC) Fraction and Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction in Alzheimer Disease, Alzheimer Dementia and Vascular Dementia, sponsored by MD Stem Cells. Enrolling by invitation at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-15.

Sponsored by MD Stem Cells · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a means to improve cognitive impairment as occurs in Alzheimer's Disease and other dementias and to improve behavior and socialization issues which occur in adult Autism Spectrum Disorder. The use of Near Infrared Light, in conjunction with the use of BMSC, will also be assessed.

Read the detailed description

Cognition is the process of generating thoughts, recalling memories, processing information, and higher order associations including social interactivity that all take place in the brain. It requires sufficient health and interactivity of neurons in the brain including their ability to form and maintain synaptic connections.

Cognitive impairment results from the loss of these abilities. ACIST will test the hypothesis that the delivery of Bone Marrow Derived Stem Cells (BMSC) via the methods in the study with or without the addition of Near Infrared Light will improve cognition through the ability of BMSC to positively affect the health and function of neurons and the brain.

Patients enrolling with cognitive impairment will require assessment with the Mini-Mental Status Exam (MMSE). A score of 24 or less will be required. Progressive dementias such as Alzheimer's Disease (ALZ) show a decline of 2 to 4 points per year on MMSE. The goal for ACIST in progressive and stable dementia will be stability over the 1 year follow up and ideally an improvement of 3 points on MMSE.

Patients enrolling with Autism Spectrum Disorder (ASD) will be required to be adults (over 18 years of age) and to have a score on the Autism Spectrum Quotient of 20 or above. The goal will be a decrease of 5 or more on the scale over the 1 year follow up period.

02

Conditions studied

  • Alzheimer Disease
  • Alzheimer Dementia
  • Vascular Dementia
  • Lewy Body Disease
  • Lewy Body Dementia With Behavioral Disturbance (Disorder)
  • Dementia, Mixed
  • Parkinson-Dementia Syndrome
  • Chronic Traumatic Encephalopathy
  • Huntington's Dementia
  • Wernicke Korsakoff Syndrome
  • Traumatic Brain Injury
  • Dementia, Multi-Infarct
  • Autism
  • Autism Spectrum Disorder
  • Autistic Behavior
  • Autistic Disorder, Current or Active State
  • Cadasil
  • LATE Limbic-predominant Age-related TDP-43 Encephalopathy

Keywords

  • Dementia
  • Alzheimer's Disease
  • CADASIL
  • Autism Spectrum Disorder
  • Adult Autism
  • High Functioning Autism
  • Asperger's Syndrome
  • CTE Chronic Traumatic Encephalopathy
  • TBI Traumatic Brain Injury
  • LATE Limbic-predominant Age-related TDP-43 Encephalopathy
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

MD Stem Cells is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Have documented cognitive impairment or diagnosis of disease associated with cognitive impairment such as Alzheimer's Disease, Autism Spectrum Disorder.
  2. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated cognitive impairment as a result of the ongoing pharmacologic or surgical treatment.
  3. In the estimation of the investigator have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
  4. Be over the age of 18
  5. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.

Exclusion criteria

Exclusion Criteria:

  1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology.
  2. Patients must be capable and willing to undergo follow up neurologic exams with the the investigators or their own neurologists as outlined in the protocol.
  3. Patients or their designated responsible party for medical decisions must be capable of providing . Cognitive or memory impairment does not necessarily mean the patient is incapable of giving informed consent. They may simply need more time to process or repetition of the content of the consent to reach understanding and provide informed consent.
  4. In the estimation of the investigator the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function.
  5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.
  6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Arm 1

    Intravenous Bone Marrow Stem Cell (BMSC) Fraction

    Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction

  • Active comparator
    Arm 2

    Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure .

    Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction · Procedure: Near Infrared Light

  • Active comparator
    Arm 3

    Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction.

    Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction · Procedure: Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction

Interventions

  • ProcedureIntravenous Bone Marrow Stem Cell (BMSC) Fraction

    14 cc of BMSC fraction separated from bone marrow aspirate and filtered with 150 micron filter and administered intravenously.

  • ProcedureIntranasal Topical Bone Marrow Stem Cell (BMSC) Fraction

    Approximately 1 cc of BMSC fraction separated from bone marrow aspirate and administered to the nasal mucosa topically.

  • ProcedureNear Infrared Light

    Near Infrared Light will be administered using an FDA cleared medical device on the preoperative day and the first postoperative day as tolerated to the general area of the frontal bone.

06

What researchers measure

Primary outcomes

  1. Mini-Mental Status Exam (MMSE)

    In cognitive impairment patients this standard cognitive function test will be administered. The change from pretreatment baseline to each time point post treatment will be assessed.

    Time frame: 1,3,6 and 12 months post treatment.

  2. Autism Spectrum Quotient Exam

    Patients with Autism Spectrum Disorder (ASD) or Autism will undergo testing with the Autism Spectrum Quotient (AQ) Exam, an autism assessment for adults. The change in scoring from pretreatment baseline to each time point post treatment will be assessed.

    Time frame: 1,3,6 and 12 months post treatment.

Secondary outcomes

  1. Activities of Daily Living

    The patients, friends and family will describe changes in abilities to function on a day to day basis.

    Time frame: 1,3,6,and 12 months post treatment

07

Study locations

3 sites
08

References and documents

Publications

  • Danielyan L, Schafer R, von Ameln-Mayerhofer A, Buadze M, Geisler J, Klopfer T, Burkhardt U, Proksch B, Verleysdonk S, Ayturan M, Buniatian GH, Gleiter CH, Frey WH 2nd. Intranasal delivery of cells to the brain. Eur J Cell Biol. 2009 Jun;88(6):315-24. doi: 10.1016/j.ejcb.2009.02.001. Epub 2009 Mar 25. PubMed 19324456 ↗
  • Duncan T, Valenzuela M. Alzheimer's disease, dementia, and stem cell therapy. Stem Cell Res Ther. 2017 May 12;8(1):111. doi: 10.1186/s13287-017-0567-5. PubMed 28494803 ↗
  • Johnstone DM, Moro C, Stone J, Benabid AL, Mitrofanis J. Turning On Lights to Stop Neurodegeneration: The Potential of Near Infrared Light Therapy in Alzheimer's and Parkinson's Disease. Front Neurosci. 2016 Jan 11;9:500. doi: 10.3389/fnins.2015.00500. eCollection 2015. PubMed 26793049 ↗
  • Robbins JP, Price J. Human induced pluripotent stem cells as a research tool in Alzheimer's disease. Psychol Med. 2017 Nov;47(15):2587-2592. doi: 10.1017/S0033291717002124. Epub 2017 Aug 14. PubMed 28805182 ↗
  • Park SE, Lee NK, Na DL, Chang JW. Optimal mesenchymal stem cell delivery routes to enhance neurogenesis for the treatment of Alzheimer's disease: optimal MSCs delivery routes for the treatment of AD. Histol Histopathol. 2018 Jun;33(6):533-541. doi: 10.14670/HH-11-950. Epub 2017 Nov 29. PubMed 29185257 ↗
  • Shroff G. Human Embryonic Stem Cells in the Treatment of Autism: A Case Series. Innov Clin Neurosci. 2017 Apr 1;14(3-4):12-16. eCollection 2017 Mar-Apr. PubMed 28584692 ↗
  • Chez M, Lepage C, Parise C, Dang-Chu A, Hankins A, Carroll M. Safety and Observations from a Placebo-Controlled, Crossover Study to Assess Use of Autologous Umbilical Cord Blood Stem Cells to Improve Symptoms in Children with Autism. Stem Cells Transl Med. 2018 Apr;7(4):333-341. doi: 10.1002/sctm.17-0042. Epub 2018 Feb 6. PubMed 29405603 ↗
  • Weiss JN, Levy S. Neurologic Stem Cell Treatment Study (NEST) using bone marrow derived stem cells for the treatment of neurological disorders and injuries: study protocol for a nonrandomized efficacy trial. Clin Trials Degener Dis. 2016 [cited 2019 Jun 18];1:176-80.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2018 (actual). Primary completion is estimated for Jul 2025, 81 months after the start.

Of 77 industry-sponsored interventional studies with no phase under Alzheimer Disease, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 81 months is above that.

Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2018
First posted
Oct 30, 2018
StartActual
Oct 24, 2018
Primary completionEst.
Jul 31, 2025
CompletionEst.
Jul 31, 2025
Last update
Apr 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03724136
Lead sponsor
MD Stem Cells
Responsible party
Sponsor
First posted
Oct 30, 2018
Start date
Oct 24, 2018
Primary completion
Jul 31, 2025 (estimated)
Completion
Jul 31, 2025 (estimated)
Last update
Apr 15, 2024

Study contacts

Steven Levy, MD
study chair · MD Stem Cells
Jeffrey Weiss, MD
principal investigator · Coral Springs

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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