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Neurologic Stem Cell Treatment Study

Neurologic Bone Marrow Derived Stem Cell Treatment Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether stem cells taken from a person's own bone marrow can improve how their nervous system works. The cells are placed into the blood vessel system and the lower part of the nose. It is for adults with certain nerve, brain, or spinal cord conditions that are unlikely to improve with standard care.

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have documented damage affecting how your brain, spinal cord, or nerves work that is unlikely to improve with standard care.
  • Have had the condition for at least 6 months.
  • If you are getting medicine or surgery for the condition, be stable on that treatment and unlikely to have the nerve damage reversed by it.
  • Dr. Weiss and the nerve specialists must think the stem cell treatment could help you and has very little risk of harm.
  • Be older than 18 and able to understand the study and agree to take part.
  • Be in stable health, with approval from your primary care provider to have the procedure without major health risks.

Who can't join

  • Cannot take part in or cooperate with an exam to check and document your nervous system condition.
  • Cannot or will not attend follow-up nervous system exams with the study doctors or your own nerve specialist as required by the study.
  • Cannot understand the study and agree to take part.
  • Dr. Weiss thinks collecting or giving the stem cells would pose a major risk to your health or nervous system.
  • Your health is not stable, or the procedure could put your health at major risk.
  • Are pregnant at the time of treatment. Women who can become pregnant should avoid pregnancy for 3 months after treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

CT

FL