Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease

October 4, 2011 updated by: Guangzhou General Hospital of Guangzhou Military Command

PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease.

The study is a phase I/II trial designed to establish the safety and efficacy of intravenous administration of autologous bone marrow derived mesenchymal stem cells to patients with Parkinson's disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Parkinson's disease (PD) is a common progressive neurodegenerative disorder caused by the loss of dopaminergic neurons in the substantia nigra. A combination of genetic and environmental factors is likely to be important in producing abnormal protein aggregation within select groups of neurones, leading to cell dysfunction and then death. A large number of agents together with surgical interventions are now available to treat early and late complications of PD, but they are suffer from two main drawbacks: side effects and loss of efficacy with disease progression.

Bone marrow (BM) derived mesenchymal stem cells (MSCs) an differentiate under certain circumstances into cells from various neuronal and glial type lineages; they also exert immunomodulatory effects. PD-derived MSCs are similar to normal MSCs in phenotype, morphology, and multidifferentiation capacity. Moreover, PD-derived MSCs are capable of differentiating into neurons in a specific medium with up to 30% having the characteristics of dopamine cells. These findings indicate that MSCs derived from PD patients' bone marrow may be a promising cell type for cellular therapy.

BM-MSCs cultured with a cocktail of growth factors (containing FGF and BDNF) differentiate into neuronal/glial lineage cells with a predominance of cells expressing astrocytes' markers. They were effective in suppression of chronic EAE in mice and induced neuroprotection, preserving most of the axons in the CNS of successfully-treated animals. Histopathological studies revealed that MSCs could efficiently migrate into the CNS inflamed tissue (both when administered intravenously and intraventricularly) and differentiated into cells expressing neural-glial lineage markers. Such an approach may provide a feasible and practical way for PD.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangzhou General Hospital of Guangzhou Military Command

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with current diagnosis of idiopathic Parkinson's disease.
  • Age 30 to 65.
  • Experiencing motor complications despite optimized levodopa treatment.
  • PD of Stage 2，2.5，3 or 4 of Hoehn-Yahr staging.
  • Time between diagnosis and enrollment greater than 2 years.
  • No significant cognitive impairment. MMSE > 24.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents within 4 weeks of study entry.
  • History of allergic reactions attributed to compounds of similar biologic composition to mesenchymal stem cells.
  • Primary hematologic diseases.
  • Patients undergo intracranial surgeries or implantation of a device for Parkinson's disease.
  • Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent and perform all study assessments.
  • Atypical or secondary parkinsonism.
  • Malignancy within the last 5 years.
  • Any other serious medical illness that might preclude safe participation in the study.
  • Pregnant or breastfeeding women.
  • HIV-positive patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MSC
Intravenous autologous bone marrow derived mesenchymal stem cells infusion to patients with Parkinson's disease.
Biological: bone marrow derived mesenchymal stem cells
Intravenous administration of up to 6x10^5 MSCs per kg,qw,for 4 weeks
Other Names:
  • Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stem Cells
  • Multipotent Mesenchymal Stromal Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 1 month after transplantation
1 month after transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect assessment
Time Frame: 1 month after transplantation
Assessed by Unified Parkinson's Disease Rating Scale (UPDRS).
1 month after transplantation
Effect assessment
Time Frame: 3 months after transplantation
Assessed by UPDRS
3 months after transplantation
Effect assessment
Time Frame: 6 months after transplantation
Assessed by UPDRS
6 months after transplantation
Effect assessment
Time Frame: 12 months after transplantation
Assessed by UPDRS
12 months after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou General Hospital of Guangzhou Military Command

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (ESTIMATE)

October 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-2011-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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