Treatment for neurologic disorders using stem cells

Neurologic Bone Marrow Derived Stem Cell Treatment Study

This study is testing whether using stem cells from patients' own bone marrow can help improve brain and nerve function in people with serious neurologic disorders that don't respond well to regular treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MD Stem Cells (industry)
• Locations: 3 sites (Westport, Connecticut and 2 other locations)
• Trial ID: NCT02795052 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the use of autologous bone marrow-derived stem cells (BMSC) to improve neurologic function in patients with various neurologic disorders. Participants will receive BMSC through intravenous administration and topical application in the nasal passages. The study aims to explore the effectiveness of this treatment approach, particularly in patients with documented functional damage to the nervous system that is unlikely to improve with standard care. The researchers hope to contribute to the existing literature on BMSC treatment for neurologic conditions.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with documented neurologic damage who are at least 6 months post-onset of their condition and stable on current treatments.

Not a fit: Patients with neurologic conditions that are expected to improve with standard care or those who are not medically stable may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to significant improvements in neurologic function for patients suffering from debilitating neurologic disorders.

How similar studies have performed: Previous studies have shown promising results with BMSC treatment for neurologic diseases, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.
2. Be at least 6 months post-onset of the disease.
3. 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 neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.
4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
5. Be over the age of 18 and capable of providing informed consent.
6. 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:

1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.
2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.
3. Patients must be capable of providing informed consent.
4. In the estimation of Dr. Weiss 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.

Where this trial is running

Westport, Connecticut and 2 other locations

• MD Stem Cells — Westport, Connecticut, United States (RECRUITING)
• MD Stem Cells — Coral Springs, Florida, United States (RECRUITING)
• The Saudi-German Hospital — Dubai, United Arab Emirates (RECRUITING)

Study contacts

• Principal investigator: Jeffrey Weiss, MD — Coral Springs, Florida
• Study coordinator: Steven Levy, MD

Conditions: Neurologic Disorders, Nervous System Diseases, Neurodegenerative Diseases, Neurological Disorders, Stroke, Traumatic Brain Injury, Cadasil, Chronic Traumatic Encephalopathy