Intranasal treatment of central nervous system dysfunction in humans.
Colin D Chapman, William H Frey, Suzanne Craft...
https://pubmed.ncbi.nlm.nih.gov/23135822Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02795052
Neurologic Bone Marrow Derived Stem Cell Treatment Study
Led by MD Stem Cells · Updated on 2025-06-06
500
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of autologous bone marrow derived stem cells (BMSC) delivered intravenously and intranasally to improve neurologic function in patients with various neurologic conditions. The study focuses on patients with documented functional damage to the central or peripheral nervous system that is unlikely to improve with current standard care. The investigators seek to add to existing knowledge by studying the effects of BMSC in conditions such as stroke, traumatic brain injury, Parkinson's disease, Alzheimer's disease, and other neurodegenerative disorders. The treatment involves collecting the participant's own bone marrow to isolate stem cells, which are then given through an intravenous infusion and applied topically to the lower third of the nasal passages on both sides. This intranasal approach targets the trigeminal nerve pathways that may help the stem cells enter the brain and central nervous system. Participants receive this combined intravenous and intranasal BMSC treatment during the study period. Participants will undergo neurologic function assessments at baseline and at 1, 3, 6, and 12 months after treatment to measure changes. They will be monitored through neurologic exams and evaluations to track potential improvements and safety. Medical stability and clearance by a primary care physician are required before treatment, and follow-up visits with neurologists are part of the study to observe outcomes over one year.
CONDITIONS
Brief Title
Neurologic Stem Cell Treatment Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have documented functional damage to the central or peripheral nervous system unlikely to improve with current standard care
- Be at least 6 months post-onset of the neurologic disease
- Be stable on any current medical or surgical treatment for the condition
- Be assessed by investigators as having potential for improvement with stem cell treatment and low risk of harm
- Be 18 years or older and capable of providing informed consent
- Be medically stable and cleared by a primary care physician to undergo the procedure
You will not qualify if you...
- Must be capable of undergoing thorough neurologic examination and evaluation
- Must be willing and able to attend follow-up neurologic exams as required
- Must be capable of providing informed consent
- Must be assessed as having low risk of harm from stem cell collection and treatment
- Must be medically stable and not at significant health risk from the procedure
- Women of childbearing age must not be pregnant and should avoid pregnancy for 3 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single treatment session with follow-up assessments
Participants receive autologous bone marrow derived stem cells administered intravenously and intranasally to the lower third of the nasal passages.
1 treatment visit followed by multiple follow-up visits at 1, 3, 6, and 12 months
Trial Site Locations
Total: 3 locations
1
MD Stem Cells
Westport, Connecticut, United States, 06880
Actively Recruiting
2
MD Stem Cells
Coral Springs, Florida, United States, 33065
Actively Recruiting
3
The Saudi-German Hospital
Dubai, United Arab Emirates, 337-1500
Actively Recruiting
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Research Team
S
Steven Levy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Intranasal delivery of stem cells to the brain.
Yongjun Jiang, Juehua Zhu, Gelin Xu...
https://pubmed.ncbi.nlm.nih.gov/21417782Autologous intravenous mononuclear stem cell therapy in chronic ischemic stroke.
A Bhasin, Mv Srivastava, R Bhatia...
https://pubmed.ncbi.nlm.nih.gov/24693196Mesenchymal stem cells secretome: a new paradigm for central nervous system regeneration?
Fábio G Teixeira, Miguel M Carvalho, Nuno Sousa...
https://pubmed.ncbi.nlm.nih.gov/23456256The use of stem cells in regenerative medicine for Parkinson's and Huntington's Diseases.
L Lescaudron, P Naveilhan, I Neveu
https://pubmed.ncbi.nlm.nih.gov/22963567Mesenchymal stem cells for the treatment of neurological diseases: Immunoregulation beyond neuroprotection.
Alice Laroni, Nicole Kerlero de Rosbo, Antonio Uccelli
https://pubmed.ncbi.nlm.nih.gov/26296458Intravenous transplantation of bone marrow mesenchymal stem cells promotes neural regeneration after traumatic brain injury.
Fatemeh Anbari, Mohammad Ali Khalili, Ahmad Reza Bahrami...
https://pubmed.ncbi.nlm.nih.gov/25206912Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology.
D Cella, J-S Lai, C J Nowinski...
https://pubmed.ncbi.nlm.nih.gov/22573626The neurology quality-of-life measurement initiative.
David Cella, Cindy Nowinski, Amy Peterman...
https://pubmed.ncbi.nlm.nih.gov/21958920