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Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia

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ClinicalTrials.gov Identifier: NCT01360164
Recruitment Status : Unknown
Verified November 2012 by Shenzhen Beike Bio-Technology Co., Ltd..
Recruitment status was:  Recruiting
First Posted : May 25, 2011
Last Update Posted : November 28, 2012
Sponsor:
Collaborators:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The Affiliated Nanjing Brain Hospital of Nanjing University Medical School
Nanjing University Medical College Affiliated Wuxi Second Hospital
Xuzhou Medical University
The Second Hospital of Nanjing Medical University
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.

May 23, 2011
May 25, 2011
November 28, 2012
January 2010
December 2012   (Final data collection date for primary outcome measure)
  • scores of International Cooperative Ataxia Rating Scale (ICARS) scale and Berg Scale [ Time Frame: 1 year after treatment ]
  • the volume of Cerebellum of Brain Magnetic Resonance Imaging (MRI) Scan [ Time Frame: 1 year after treatment ]
  • scores of ICARS scale and Berg Scale [ Time Frame: 1 year after treatment ]
  • the volume of Cerebellum of Brain MRI Scan [ Time Frame: 1 year after treatment ]
Complete list of historical versions of study NCT01360164 on ClinicalTrials.gov Archive Site
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year after treatment ]
  • Number of Participants with Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 1 year after treatment ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia
Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia
The Hereditary Ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and often associated with poor coordination of hands, speech, and eye movements. Current treatments for Hereditary Ataxias are mainly pharmacological, rehabilitative, or psychological treatments,while no effective treatment available. Stem Cell therapy is a novel and promising therapeutic strategy for Hereditary Ataxias treatment. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with Hereditary Ataxias.
This Study is designed to evaluate the the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation in patients with Hereditary Ataxias.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hereditary Ataxia
Biological: human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.
Other Name: Intervention Group
Experimental: Human umbilical cord mesenchymal stem cells transplantation
Participants will be given umbilical cord mesenchymal stem cells transplantation with a 1 year follow-up.
Intervention: Biological: human umbilical cord mesenchymal stem cells
Jin JL, Liu Z, Lu ZJ, Guan DN, Wang C, Chen ZB, Zhang J, Zhang WY, Wu JY, Xu Y. Safety and efficacy of umbilical cord mesenchymal stem cell therapy in hereditary spinocerebellar ataxia. Curr Neurovasc Res. 2013 Feb;10(1):11-20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
Same as current
December 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 16-65 years.
  • Harding Diagnosis of SCAs, gene type confirmed.
  • Candidates who did not receive any stem cell therapy in past 6months.
  • sign the consent form and follow the clinic trail procedure.

Exclusion Criteria:

  • Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value;
  • Routine Blood Test: WBC count <3.0×109/ L; PLT count <5×109/L ; or Hemoglobin <100g/L;
  • Combined Pneumonia or other Severe systemic bacteria infection;
  • Severe drug allergic history or anaphylaxis to 2 or more food or medicine;
  • Other brain organic disease (eg. Brain cancer);
  • HIV+, Tumor Markers + ;
  • Severe psychotic patients, cognitive dysfunction, or can not understand or sign the Consent Form;
  • Other severe systemic or organic disease;
  • Uncontrolled hypertension,blood pressure≥180mmHg/110 mmHg after treatment;
  • Pregnancy;
  • Enrollment in other trials in the last 3 months;
  • Other criteria the investigator consider improper for inclusion.
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01360164
BKCR-HA-1.0(2010)
Yes
Not Provided
Not Provided
Shenzhen Beike Bio-Technology Co., Ltd.
Shenzhen Beike Bio-Technology Co., Ltd.
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  • The Affiliated Nanjing Brain Hospital of Nanjing University Medical School
  • Nanjing University Medical College Affiliated Wuxi Second Hospital
  • Xuzhou Medical University
  • The Second Hospital of Nanjing Medical University
Not Provided
Shenzhen Beike Bio-Technology Co., Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP