Autologous Stem Cell Therapy in Patients With Multiple System Atrophy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age35-65
SponsorBiocells Medical
About this trial
This study investigates the safety and efficacy of autologous stem cell therapy in patients with Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disorder characterized by autonomic failure, parkinsonism, and cerebellar ataxia. The trial will evaluate functional outcomes, motor performance, and quality of life compared to placebo/controlled group.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Multiple System Atrophy (MSA-P or MSA-C)
Age range of 35 to 65 years
Disqualifiers
Other major neurological disorders
Severe cardiac/renal/hepatic impairment
Prior stem cell therapy
Trial design
Design model
Parallel
Treatments tested in this trial
MSCs
DrugIV infusion of 200,000,000 of neuroinduced mesynchimal stem cells at week 1 of the trial period
Placebo
Other interventionIntravenous 0.9% saline infusion, volume- and appearance-matched
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: MSC therapyExperimental treatment 1 intervention
Group B: Saline SolutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Unified Multiple System Atrophy Rating Scale (UMSARS)
Time frame
At week 48 from baselineSecondary outcomes
1
Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36)
Change in Health-Related Quality of Life as Measured by the 36-Item Short Form Health Survey (SF-36) Total Score with Range: 0-100 where 0 is the lowest value and 100 is the highest; higher scores indicate better health-related quality of life at Week 48
Time frame
At week 48 from baselineSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: