Table 2.
Current clinical trials on stem cell therapy for Amyotrophic Lateral Sclerosis.
| Title | Brief Summary | Intervention in Experimental Arm | Primary Outcome | Status | NCT Number |
|---|---|---|---|---|---|
| Clinical Trial in Phase II of Intramuscular Infusion of Autologous Bone Marrow Stem Cells in Patients with Amyotrophic Lateral Sclerosis | The purpose of this study is to assess the positive effects of autologous bone marrow mononuclear cells (BMNC) injection on the natural loss of motor units and on the increase in the size of the motor unit that occurs in patients with ALS during the evolution of the disease. | Intramuscular infusion of autologous BMNC into the transverse abdominal (TA) muscle of one of the lower limbs versus intramuscular infusion of saline solution (placebo) in the TA muscle of the contralateral side. | Rate of serious and non-serious adverse events related to the use of bone marrow mononuclear cells in patients with Amyotrophic Lateral Sclerosis. D50 index obtained from stimulus intensity curves. |
Not yet recruiting | NCT04849065 |
| The Evaluation of the Effect of Wharton’s Jelly Mesenchymal Stem Cells (WJMSCs) on the Immune System of Patients with Amyotrophic Lateral Sclerosis | The objective of this study is to evaluate the safety of intrathecal administration of WJMSCs and the impact on the immune system of patients with Amyotrophic Lateral Sclerosis. | Three intrathecal administration of mesenchymal stem cells isolated from Wharton’s jelly. | Number of Serious Adverse Event of Special Interest (S)AESI, including meningitis, toxic encephalopathy encephalitis, high fever, and epileptic seizures not connected to conditions above. | Recruiting | NCT04651855 |
| A Phase II Study of Intrathecal Autologous Adipose-derived Mesenchymal Stromal Cells for Amyotrophic Lateral Sclerosis | The purpose of this open label, Phase II multi-site clinical study is to determine the safety and efficacy of intrathecal treatment delivered to the cerebrospinal fluid (CSF) of mesenchymal stem cells in ALS patients every 3 months for a total of 4 injections over 12 months. | Autologous adipose-derived Mesenchymal Stromal Cells (aaMSCs) will be administered intrathecally at a single dose suspended in 5-10 mL Lactated Ringer’s. Reduced dose treatments will be allowed based on specific adverse events. | Number of adverse events recorded from the time of enrollment until the end of the follow-up period or, in the case of early withdrawal, to the time of study withdrawal. | Recruiting | NCT03268603 |
| A Phase 1/2a Open-Label Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects with Amyotrophic Lateral Sclerosis (ALS): Assessment of Localized Therapeutic Activity by Blinded Observation and Lateral Transplantation (ALTA-BOLT) | This study is a non-randomized, open-label, partially blinded, sequential cohort, dose-escalation study designed to obtain preliminary data on the safety, tolerability, and early efficacy of hGRPs transplantation in subjects with ALS. Following an initial cohort receiving cell transplants unilaterally in the lumbar spinal cord, subsequent cohorts will receive escalating doses transplanted unilaterally in cervical spinal cord. Subjects and outcome measure assessors will be blinded to side of treatment. | Unilateral lumbar surgical transplantation of human cells of the glial lineage. | Safety measured by the number of therapy-related adverse events. | Not yet recruiting | NCT02478450 |
| A Multicenter Phase I/II Clinical Trial, Randomized, Controlled with Placebo, Triple Blind to Evaluate Safety, and Indications of Efficiency of the Intravenous Administration of the Therapy With 3 Doses of MSC in Patients with ASL Moderated to Severe | This is a multicenter phase I/II randomized, controlled with placebo, triple blind clinical trial aimed to evaluate the safety of intravenous administration of 3 doses of autologous mesenchymal stem cells from adipose tissue in patients with Amyotrophic Lateral Sclerosis. Forty patients will be enrolled and randomized into one of four arms and the follow-up phase, from the cell infusion/placebo, will be 6 months. | Intravenous administration of MSCs at different doses. | Number of adverse serious unexpected reactions or not, attributable to the treatment. Complications in the place of the infusion. Appearance of new neurological effect not attributable to the natural progression of pathology. |
Active, not recruiting | NCT02290886 |