Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study
NCT ID: NCT03724136
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
100 participants
INTERVENTIONAL
2018-10-24
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Intravenous Bone Marrow Stem Cell (BMSC) Fraction
Intravenous 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.
Arm 2
Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure .
Intravenous 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.
Near 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.
Arm 3
Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction.
Intravenous 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.
Intranasal 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.
Interventions
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Intravenous 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.
Intranasal 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.
Near 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.
Eligibility Criteria
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Inclusion Criteria
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
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 informed consent. 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.
18 Years
ALL
No
Sponsors
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MD Stem Cells
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Levy, MD
Role: STUDY_CHAIR
MD Stem Cells
Jeffrey Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Coral Springs
Locations
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MD Stem Cells
Westport, Connecticut, United States
MD Stem Cells
Coral Springs, Florida, United States
Medcare Orthopaedics & Spine Hospital
Dubai, , United Arab Emirates
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Report from CNN on Duke University stem cell autism study
Other Identifiers
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MDSC-ACIST
Identifier Type: -
Identifier Source: org_study_id
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