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

NCT ID: NCT01360164

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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This Study is designed to evaluate the the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation in patients with Hereditary Ataxias.

Conditions

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Hereditary Ataxia

Keywords

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Human Umbilical Cord Mesenchymal Stem Cells

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Human umbilical cord mesenchymal stem cells transplantation

Participants will be given umbilical cord mesenchymal stem cells transplantation with a 1 year follow-up.

Group Type EXPERIMENTAL

human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

Participants will be given hUC-MSCs transplantation.

Interventions

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human umbilical cord mesenchymal stem cells

Participants will be given hUC-MSCs transplantation.

Intervention Type BIOLOGICAL

Other Intervention Names

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Intervention Group

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role collaborator

Nanjing University Medical College Affiliated Wuxi Second Hospital

UNKNOWN

Sponsor Role collaborator

Xuzhou Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Shenzhen Beike Bio-Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanjing University Medical College Affiliated Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yun Xu

Role: CONTACT

Email: [email protected]

Facility Contacts

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Yun Xu

Role: primary

References

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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. doi: 10.2174/156720213804805936.

Reference Type DERIVED
PMID: 23151076 (View on PubMed)

Other Identifiers

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BKCR-HA-1.0(2010)

Identifier Type: -

Identifier Source: org_study_id