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Completed

NCT Number: NCT01649687

Treatment of Cerebellar Ataxia With Mesenchymal Stem Cells

The study is to investigate the efficacy and safety of allogenous transplantation of adipose-derived mesenchyma stem cells in patients with cerebellar ataxia.

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Key information

Conditions

Cerebellar Ataxia Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Diseases Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Taipei Veterans General Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed of spinocerebellar ataxia 3 (SCA3) or multiple system atrophy-cerebellar (MSA-C).
  • Subject's SARA score at 10~20 points.
  • Ages between 20~70 years.
  • Signed informed consent from the patient and/or guardian.

Exclusion criteria

  • Subjects enrolled in any other cell therapy studies within the past 30 days.
  • Pregnancy test positive.
  • Subjects deemed to be not suitable for the study by the investigator.

Treatment and study plan

Allogeneic adult adipose-derived mesenchymal stem cells

Biological

Patients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells

Primary outcomes

  1. Safety evaluation

    Time frame: 12 months

    Safety evaluate through vital signs, the results of clinical lab tests and adverse events (AEs)

Secondary outcomes

  1. Alterations in SARA score

    Time frame: 12 months

  2. Positron emission tomography

    Time frame: 9 months

    18F-FDG used for the assessment of glucose metabolism in the brain

  3. Magnetic resonance spectroscopy

    Time frame: 12 months

    NAA/Cr,Cho/Cr,NAA/Cho ratios to reflect neuronal/cerebral white mater integrity

  4. Assessment of language and swallowing functions

    Time frame: 12 months

    changes in levels of severity: normal/slight/mild/moderate/severe

  5. Evaluation of syncope

    Time frame: 12 months

    Tilt table test

  6. Balance test

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2012
Registry last updated
Sep 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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