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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Intravenous Bone Marrow Stem Cell (BMSC) Fraction |
|
| Arm 2 | Active Comparator | Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure . |
|
| Arm 3 | Active Comparator | Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Bone Marrow Stem Cell (BMSC) Fraction | Procedure | 14 cc of BMSC fraction separated from bone marrow aspirate and filtered with 150 micron filter and administered intravenously. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1,3,6 and 12 months post treatment. |
| 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. | 1,3,6 and 12 months post treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Activities of Daily Living | The patients, friends and family will describe changes in abilities to function on a day to day basis. | 1,3,6,and 12 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Levy, MD | MD Stem Cells | Study Chair |
| Jeffrey Weiss, MD | Coral Springs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Stem Cells | Westport | Connecticut | 06880 | United States | ||
| MD Stem Cells |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19324456 | Background | 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. | |
| 28494803 | Background |
| Label | URL |
|---|---|
| Report from CNN on Duke University stem cell autism study | View source |
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Patients will be assigned to one of 3 arms with monitoring and retesting at 1,3,6 and 12 months following treatment.
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| Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction | Procedure | Approximately 1 cc of BMSC fraction separated from bone marrow aspirate and administered to the nasal mucosa topically. |
|
| Near Infrared Light | Procedure | 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. |
|
| Coral Springs |
| Florida |
| 33065 |
| United States |
| Medcare Orthopaedics & Spine Hospital | Dubai | United Arab Emirates |
| 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. |
| 26793049 | Background | 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. |
| 28805182 | Background | 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. |
| 29185257 | Background | 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. |
| 28584692 | Background | 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. |
| 29405603 | Background | 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. |
| Background | 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. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D015140 | Dementia, Vascular |
| D020961 | Lewy Body Disease |
| D000093902 | Mixed Dementias |
| C537240 | Progressive supranuclear palsy atypical |
| D000070627 | Chronic Traumatic Encephalopathy |
| D020915 | Korsakoff Syndrome |
| D000070642 | Brain Injuries, Traumatic |
| D015161 | Dementia, Multi-Infarct |
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D046589 | CADASIL |
| C000723354 | limbic-predominant age-related TDP-43 encephalopathy |
| D003704 | Dementia |
| D020817 | Asperger Syndrome |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D001930 | Brain Injuries |
| D020208 | Brain Injury, Chronic |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D001925 | Brain Damage, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D008569 | Memory Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D020521 | Stroke |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D065886 | Neurodevelopmental Disorders |
| D059345 | Cerebral Small Vessel Diseases |
| D002539 | Cerebral Arterial Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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