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
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Condition or disease | Intervention/treatment | Phase |
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Hereditary Ataxia | Biological: human umbilical cord mesenchymal stem cells | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Hereditary Ataxia |
Study Start Date : | January 2010 |
Estimated Primary Completion Date : | December 2012 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Human umbilical cord mesenchymal stem cells transplantation
Participants will be given umbilical cord mesenchymal stem cells transplantation with a 1 year follow-up.
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Biological: human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.
Other Name: Intervention Group
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360164
Contact: Yun Xu | xuyun20042001@yahoo.com.cn |
China, Jiangsu | |
Nanjing University Medical College Affiliated Drum Tower Hospital | Recruiting |
Nanjing, Jiangsu, China | |
Contact: Yun Xu xuyun20042001@yahoo.com.cn |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shenzhen Beike Bio-Technology Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01360164 History of Changes |
Other Study ID Numbers: |
BKCR-HA-1.0(2010) |
First Posted: | May 25, 2011 Key Record Dates |
Last Update Posted: | November 28, 2012 |
Last Verified: | November 2012 |
Keywords provided by Shenzhen Beike Bio-Technology Co., Ltd.:
Human Umbilical Cord Mesenchymal Stem Cells |
Additional relevant MeSH terms:
Ataxia Cerebellar Ataxia Spinocerebellar Degenerations Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Cerebellar Diseases Brain Diseases Central Nervous System Diseases Spinal Cord Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn |