Status:
UNKNOWN
Intraspinal Transplantation of Autologous ADRC in ALS Patients
Lead Sponsor:
Mossakowski Medical Research Centre Polish Academy of Sciences
Collaborating Sponsors:
Medical University of Warsaw
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The goal of our nonrandomized, open label study is to investigate the safety and efficacy of autologous adipose derived mesenchymal regenerative cells (ADRC) transplantation into the individuals with ...
Detailed Description
Amyotrophic Lateral Sclerosis (ALS) is an incurable disease of unknown etiology that in a short time leads to significant impairment of motor functions and death. The frequency of ALS is 4-8/100 000. ...
Eligibility Criteria
Inclusion
- clinically definite or probable ALS according to El Escorial criteria
- life expectancy of more than 1 year
- INR ≤2 before liposuction
- lack of treatment with immune-suppressants and/or corticosteroids within min. 20 days prior to recruitment
- constant riluzole treatment (50 mg/bid) throughout the study period
- compliance with treatment regimen e.g. will and possibility to attend check-up visits
- Polish citizens
Exclusion
- primary haematological disease, including hypercoagulable states
- Presence of comorbidity that would stand in the way of neurosurgical treatment-
- previous history of a spinal-cord surgery at the clinically affected level
- previous/current history of neoplasm or comorbidity that could impact upon patient's survival
- PEG
- pregnancy /lactation
- noninvasive/invasive mechanical ventilation at time of recruitment
- alcohol abuse, cocaine amphetamine, etc.
Key Trial Info
Start Date :
October 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03296501
Start Date
October 13 2015
End Date
October 31 2022
Last Update
April 15 2020
Active Locations (1)
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1
Medical University of Warsaw
Warsaw, Poland, 02-097