Individual Patient Expanded Access IND of Autologous HBadMSCs for the Treatment of Amyotrophic Lateral Sclerosis
- Identifier: NCT04514952
- Researchers from Hope Biosciences in Houston, Texas, are seeking individual patients with a documented diagnosis of ALS. The treatment will involve using Hope Bioscience’s autologous, adipose-derived culture expanded mesenchymal stem cells (HB-adMSCs). To confirm eligibility, the patients will have an initial screening visit and then will return in 1-2 weeks for a baseline/first infusion visit. After this visit, patients will be treated every 2 weeks for 18 weeks and then will have follow-up visits at weeks 22, 26, 39, and 52. The follow-up visits will involve physical examinations and laboratory tests such as blood tests and X-Rays. The patients will receive one intravenous infusion of HB-adMSCs (2×108 cells) at a volume of 250 ml of Saline Solution at a rate of 83 gts/min during each of their treatment visits. In combination with the treatments, the patients will take the ALS-specific Quality of Life Survey-revised questionnaire at the beginning of their treatment and during each of their follow up visits to measure any changes in their quality of life.
- https://clinicaltrials.gov/ct2/show/record/NCT04514952?term=Stem+Cells&cond=Lou+Gehrig+Disease&cntry=US&draw=3&rank=8
Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis (ALS)
- Identifier: NCT03268603
- Researchers from the Mayo Clinic in Rochester, Minnesota, are looking for patients with diagnosed ALS to test the safety and efficacy of intrathecal treatment delivered to the cerebrospinal fluid (CSF) of mesenchymal stem cells. Eligible patients must be 18 years old, geographically accessible to the test site, have no history of cancer or significant medical condition, and if they are female, they must be post-menopausal, have had a hysterectomy, or must be willing to employ contraception. Patients must receive a Lumbar puncture during this study to participate. Please visit the clinical trial’s site for more eligibility information. This study will involve treatment with 1 x10^8 Autologous Adipose-derived Mesenchymal Stromal Cells (aaMSCs) every 3 months for a total of 4 intrathecal injections over 12 months. The primary outcome of this study is to monitor any adverse effects seen in patients due to their treatment. To monitor the secondary outcome of this study, the patients will be rated on the ALS Functional Rating scale to keep track of any changes in their ability to complete the tasks listed on the ALSFRS-R.
- https://clinicaltrials.gov/ct2/show/record/NCT03268603?term=Stem+Cells&cond=Lou+Gehrig+Disease&cntry=US&draw=1&rank=10
Neurologic Stem Cell Treatment Study
- Identifier: NCT02795052
- Researchers from MD Stem Cells in Connecticut, Florida, and the United Arab Emirates are looking for patients with Neurologic damage due to diseases such as ALS to participate in a study that utilizes bone marrow derived stem cells (BMSC). Eligible patients must be over 18, have a disease or injury that is clinically stable, but unlikely to improve with standard methods of treatment, and must be willing to undergo neurologic examinations throughout the study. Please visit the researcher’s clinical trial site for more information about eligibility. During this study, the patients will have autologous stem cells derived from their bone marrow and cultured. The patients in this study will be separated into 2 Arms. Patients in Arm 1 will have their BMSCs injected intravenously into their blood stream. Patients in Arm 2 will receive a topical application of BMSC to the lower 1/3 of the nasal passages. The primary outcome of this study is to monitor the Activities of Daily Living of the patients at the 3,6, and 12-month marks. The secondary outcome of this study is to monitor changes in their Neurologic Functioning as compared to the baseline set at their first meeting.
- https://clinicaltrials.gov/ct2/show/study/NCT02795052?term=Stem+Cells&cond=Lou+Gehrig+Disease&cntry=US&draw=2&rank=15