Recruiting

Neurologic Stem Cells

Sponsor:

MD Stem Cells

Code:

NCT02795052

Conditions

Neurologic Disorders

Nervous System Diseases

Neurodegenerative Diseases

Neurological Disorders

Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intravenous and Intranasal BMSC

Study Details

Brief summary:

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/

Conditions

Neurologic Disorders

Nervous System Diseases

Neurodegenerative Diseases

Neurological Disorders

Stroke

Study ID

NCT02795052

Start date

Jun, 2016

Status verified date

Jun, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Arm 1- Intravenous and Intranasal BMSC

Intervention- Autologous bone marrow aspiration and separation of Bone Marrow Derived Stem Cell (BMSC) fraction then provided intravenously and intranasally (lower 1/3 of nasal passages).

Interventions

Intravenous and Intranasal BMSC

Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)

Primary outcome measure

  • Change in Neurologic Function [ Time Frame: 0,1,3,6 and 12 months ]

Central Contacts and Locations

Central contacts

Locations

MD Stem Cells

Recruiting

Westport, Connecticut, United States, 06880

Contacts

MD Stem Cells

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Principal Investigator:

Jeffrey Weiss, MD

More Information

Sponsor

MD Stem Cells

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Neurologic Disease
  • Cerebral Vascular Accident
  • Stroke
  • Traumatic Brain Injury
  • Multiple Sclerosis
  • Parkinsons Disease
  • Neuropathy
  • Diabetic Neuropathy
  • Cerebral Ischemia
  • Cognitive Impairment
  • Dementia
  • Neurodegeneration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by MD Stem Cells on 2026-06-26.