Trial | NCT03828123  Report issue

Title

Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral Sclerosis
A Prospective, Non-randomized, Open Label Study to Assess the Safety and the Efficacy of Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral Sclerosis

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    26
Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease that targets motor neurons. Prognosis is invariably fatal within 3-5 years since manifestation of the disease. Despite improved understanding of the mechanisms underlying ALS, the treatment remains essentially only supportive and focused on symptoms relief. Over the past few years, stem cell research has expanded greatly as a tool for developing new therapies to treat incurable diseases. Stem cell therapy has been shown as promising in several animal ALS models and human clinical trials.
Subjects will be assigned to autologous mesenchymal stromal cell (AMSC) treatment according to inclusion and exclusion criteria (see below) screened four times prior to administration. Then the subjects will be observed for three consecutive yearsAfter a half year of screening period, the autologous multipotent mesenchymal stromal cells from bone marrow will be isolated. The cells will be cultivated for 3 passages (3 - 4 weeks) in order to get sufficient amount for therapy, cell suspension for intrathecal application will be prepared and introduced intrathecally through lumbar puncture. Subsequently, all the subjects will be observed at the range of standard medical care used at these types of interventions.
Study Started
Jan 31
2012
Primary Completion
Aug 18
2017
Study Completion
Aug 18
2017
Last Update
Feb 12
2019

Biological Suspension of human autologous MSC 3P in 1.5 ml

Intrathecal application of Autologous Multipotent Mesenchymal Stromal Cells 3P suspension

Autologous Multipotent MSC Experimental

Patients with intrathecal administration of Suspension of human autologous MSC 3P in 1.5 ml

Criteria 

Inclusion Criteria:

established diagnosis of definite ALS according to El Escorial criteria
riluzole naive or stable dose for at least 2 months,
life expectancy more than 2 years
patients able to provide written informed consent.

Exclusion Criteria:

FVC less than 70%
in case of primary bulbar paralysis less than 15 points on Norris bulbar scale,
less than 15 points on Norris spinal scale,
pregnancy, breastfeeding
coagulopathy,
skin infection at the site of bone marrow aspiration or application of the cell product,
gastrostomy,
any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, cancer, systemic infection, recurrent thromboembolic disease .....),
alcohol or drug abuse
cancer.
women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners
fertile men not using proven contraceptive measures including effective contraception of their partner (established oral contraception, intrauterine device, ligation of the uterine tube)
No Results Posted