Recent Studies in Neurological Disorders

Adipose Stem Cells for Traumatic Spinal Cord Injury

  • gov Identifier: NCT03308565
  • The Mayo Clinic in Rochester, Minnesota is looking for males or females above the age of 18 to undergo experimental stem cell research. The clinic is seeking people above the age of 18 who have had AIS grade A or B blunt, non-penetrating injuries in the last year. The study will involve surgically harvesting mesenchymal stem cells from the patient’s fatty adipose tissue in the thigh or abdomen and then cultivating the stem cells so that they can be re-injected into the patient’s cerebrospinal fluid. The patient will be evaluated closely following the injection with intermittent check-ups for the next 96 weeks.

Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic Spinal Cord Injuries

  • gov Identifier: NCT01772810
  • Possible patients for this study include males and females ages 18-65 who have had a spinal cord injury that was non-penetrating and not a complete spinal cord transection. The researchers are looking for 2 groups of people with AIS grade A injuries that occurred less recently than 1 year ago but no longer than 2 years ago. The first group being people with injuries in section T2-T12 and the second being people with injuries in section C5-C7 who also live within 500 miles of San Diego. The study will include surgical implantation of human derived neural stem cells followed by monitoring for the 6 months following the surgery. The patient will also continue to be monitored for adverse effects in the 54 months following the completion of the study.

 Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

  • gov Identifier: NCT03225625
  • Researchers from the Healing Institute in Margate, Florida are looking for medically stable patients over the age of 18 to enter into a new study involving paraspinal stem cell injections and exoskeleton/virtual reality therapy to study their effectiveness at treating spinal cord injuries. This is a study with 3 arms: the first arm is simply injections and a follow up with the doctors, Arm 2 involves the same injection and follow up but will also be using exoskeleton therapy, and Arm 3 will be the same injection and follow up, but they will be using virtual reality therapy. The injections utilized in this study will be using bone marrow derived stem cells and injecting them into the patient in a procedure done under anesthesia. Patients in all 3 arms will be also be receiving application of stem cells applied topically in the nose and will be monitored 1, 3, 6, and 12 months following the procedure. Patients in Arm 2 will be receiving exoskeleton/ physical therapy that involves using a device that moves the muscles and ideally stimulates the motor neurons. Patients in arm 3 will be using virtual reality to simulate movement of injured limbs.

Effect of a Novel Intervention Using Daily Intermittent Hypoxia and High Intensity Training on Upper Limb Function in Individuals with Spinal Cord Injuries

  • Gov Identifier: NCT03643770
  • Patients that are at least 1-year post injury with a non-progressive spinal cord injury in levels C3-T1that are ages 18-75 are qualified for new research from the Shirley Ryan Ability Lab in Chicago, Illinois. This research involves using short periods of decreased oxygen levels (acute intermittent hypoxia) and upper body training using an exoskeleton system in hopes of seeing improvement in upper body strength and dexterity. The subjects will receive acute intermittent hypoxia in a screening visit and must see an increase in isometric elbow flexion force in order to be approved for the research. Once approved, the patients will be placed into 2 groups and will receive either acute intermittent hypoxia or a placebo of hypoxia while exercising using a robotic upper extremity aid. The patients will do these exercises daily for a month and will be tested at the completion of the study for grip strength, coordination, and a graded refined assessment of strength, sensation, and prehension.

Umbilical Cord Blood Cell Transplant into Injured Spinal Cord with Lithium Carbonate of Placebo Followed by Locomotor Training

  • gov Identifier: NCT03979742
  • Researchers from StemCyte Inc. in New Jersey are looking for patients aged 18-60 years old that are a year removed from an ASI grade A injury spanning less than 3 vertebrates in the area of C5 – T11. Patients must also be able to stand for at least 1 hour a day with an aid. This study involves injecting Umbilical Cord blood mononuclear stem cells into the injured spinal cord of the patient. Following injections, the patient will be given a 6-week treatment of either lithium carbonate or a placebo. These treatments will coincide with locomotion training that could involve as much as 6 hours a day, 6 days a week, for 3-6 months. The researchers will analyze the treated patients at weeks 2, 6, 8, 28, and 48 for a variety of measurements of locomotion and neurological activity.

Alzheimer’s Disease Stem Cells Multiple Infusions

    • gov Identifier: NCT04040348
    • Researchers at the University of Miami in Miami, Florida are looking for patients aged 50-85 that have a caregiver and meet the criteria for Alzheimer’s Disease (not another form of dementia) to study the effects of umbilical cord derived mesenchymal stem cell infusions. At the beginning of the study, the patients will take a mini-mental state evaluation to set a baseline. Then the patients will be split into 2 groups of a high or low dose. The low dose group will receive an infusion of 100 million stem cells 4 times (400 million total) on 13-week intervals and the high dose group will receive 200 million stem cells 4 times (800 million total) on 13-week intervals. In the immediate month following injections, patients will be monitored for any serious adverse effects of the treatment. For up to 65 weeks following their treatment, the patients and their caretaker will be answering questionnaires to gauge any improvement or decline in the patient’s mental capacity. The patients will also be tested for presence of certain proteins or amyloids in their blood.

Allogenic Human Mesenchymal Stem Cells for Alzheimer’s Disease

  • gov Identifier: NCT0283379
  • Males or Females aged 50-85 that have been diagnosed with mild to moderate Alzheimer’s for at least 3 months and an Amyloid-positive florbetapir PET scan qualify for new research trials at the John Wayne Cancer Institute in Santa Monica, CA. This treatment involves 2 groups, the first will receive 1.5 million human mesenchymal stem cells per kilogram of body weight intravenously and then 6 months later will receive a placebo dose of lactated Ringer’s solution. The second group will receive Ringer’s solution first and then the stem cells 6 months later. The patients will be monitored for 18 months by the researchers for improvement and the study will be monitored for safety by an independent review board.

Alzheimer’s Autism and Cognitive Impairment Stem Cell Treatment Study

  • gov Identifier: NCT03724136
  • Researchers from MD Stem Cells with locations in Westport, Connecticut and Coral Springs, Florida are looking for patients to study the effects of bone marrow derived stem cells on Alzheimer’s disease as well as other forms of dementia and people on the Autism spectrum. Eligible patients must b over the age of 18 and suffering from a cognitive impairment due to a diagnosed disease such as Alzheimer’s or Autism. Before the study, the patients will receive a mental evaluation to set a baseline for cognitive ability. The study will be divided into three groups. All patients will be injected intravenously with bone marrow derived stem cells. 1/3 of patients will receive only this injection and another 1/3 will receive this injection as well as a topical application of these stem cells to their nose. The final 1/3 of patients will receive the injections as well as treatment with near infrared light. After treatment, the patients will be receiving the same cognitive test they took before the study at months 1, 3, 6, and 12 following treatment to monitor for improvement. People close to the patients will also be asked during the same 1, 3, 6, and 12 month period if they notice any improvements in the day to day cognitive ability of the patient.

 Autologous Stem/Stromal Cells in Neurological Disorders and Disease

  • gov Identifier: NCT03297177
  • Researchers from Regeneris Medical in Massachusetts are looking for patients to test the effects of treatment using autologous stem cells harvested from fat deposits on the patient’s body. Eligible patients are 18 to 90 years old and have a been suffering from a neurological disease for more than 6 months with little indication of improvement. The patients must also be able to undergo neurological testing such as an MRI and be able to provide informed consent. The first part of the study involves researchers harvesting the cells from the patients and then culturing them so that they may become isolated, sterilized, and concentrated. Following the concentration period of these cells, researchers will then be re-injecting the cells into the patients intravenously. Following treatment, the patient will be monitored on 6-month intervals for up to 5 years. The researchers will be giving the patients questionnaires and neurological examinations as well as a making sure there are no adverse effects.



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