Mesenchymal 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/26296458/Actively Recruiting
Led by MD Stem Cells · Updated on 2026-06-26
500
Participants Needed
3
Research Sites
52 weeks
Total Duration
Researchers are studying the use of autologous bone marrow derived stem cells BMSC to improve neurologic function in patients with various neurologic disorders and diseases. This study focuses on neurologic conditions that have caused functional damage unlikely to improve with current standard treatments. The trial aims to add to existing knowledge about the potential benefits of BMSC treatment, particularly using intravenous and intranasal delivery methods targeting the central nervous system. Participants receive treatment involving the collection of their own bone marrow stem cells, which are then separated and administered both intravenously and applied topically to the lower third of the nasal passages. This dual delivery approach is designed to help the stem cells reach areas of the brain via the bloodstream and along the trigeminal nerve pathways. The treatment is given as a single intervention with follow-up evaluations at multiple time points. During the study, participants will undergo neurological assessments at baseline and at 1, 3, 6, and 12 months after treatment to monitor changes in neurological function. Medical stability and ongoing safety will be evaluated by the participants primary care doctor and neurologists. The study will measure improvements in neurologic function and monitor any effects or risks related to the stem cell procedure over the course of one year following treatment.
CONDITIONS
Neurologic Stem Cell Treatment Study
S
Steven Levy, MD
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MD Stem Cells
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Intravenous and Intranasal BMSC | Established Medical Treatment |
|---|---|---|
| What it is | Autologous bone marrow-derived stem cells are administered intravenously and intranasally to participants with neurologic damage unresponsive to existing therapies. | Established medical treatment includes pharmacologic agents, rehabilitation, and in some cases surgical interventions, aiming to stabilize function and minimize further decline in neurologic disorders. |
| Role in trial | The investigational therapy is actively administered to eligible participants to evaluate potential improvement in neurologic function. | Standard care treatments serve as the baseline from which participants are selected, as they are unlikely to experience further improvement with these therapies. |
| Primary use | Potentially to restore or improve neurologic function in adults for whom current medical therapy has not been effective. | To stabilize symptoms, prevent progression, and support function through medications, rehabilitation, or surgery, without expectation of substantial recovery. |
| How it is given or performed | Stem cells collected from the participant's own bone marrow are infused intravenously and delivered intranasally, following medical clearance. | Pharmacologic treatments are administered orally, intravenously, or as injections. Surgical procedures and rehabilitation programs are performed based on individual patient needs. |
| Evidence status | There is ongoing clinical investigation; published reviews indicate preclinical and early-phase studies show immunoregulatory and neuroprotective potential, but definitive effectiveness in humans is not established. | Current therapies are supported by extensive clinical evidence for symptom management and slowing disease progression, though marked improvements in function are rare in advanced cases. |
| Important limitations | Effectiveness and long-term safety are unknown. The procedure requires invasive bone marrow collection and medical clearance; risks may include infection, procedural complications, or unknown long-term effects. | Current care generally does not restore lost neurologic function; effectiveness diminishes as disease progresses, and adverse effects from medications or surgery may occur. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment session
Participants receive their own bone marrow stem cells intravenously and applied intranasally to the lower third of the nasal passages.
1 visit (in-person)
Duration - 12 months
Participants undergo neurologic evaluations at 1, 3, 6, and 12 months after treatment to monitor changes in neurologic function.
4 visits (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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