Status:
COMPLETED
Autologous Multipotent Mesenchymal Stromal Cells in the Treatment of Amyotrophic Lateral Sclerosis
Lead Sponsor:
Bioinova, s.r.o.
Collaborating Sponsors:
University Hospital, Motol
Conditions:
Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 im...
Detailed Description
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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2017
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03828123
Start Date
January 1 2012
End Date
August 18 2017
Last Update
February 12 2019
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