Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Guangzhou General Hospital of Guangzhou Military Command.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01446614
First received: October 4, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Biological: bone marrow derived mesenchymal stem cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease.

Resource links provided by NLM:


Further study details as provided by Guangzhou General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 1 month after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effect assessment [ Time Frame: 1 month after transplantation ] [ Designated as safety issue: No ]
    Assessed by Unified Parkinson's Disease Rating Scale (UPDRS).

  • Effect assessment [ Time Frame: 3 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by UPDRS

  • Effect assessment [ Time Frame: 6 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by UPDRS

  • Effect assessment [ Time Frame: 12 months after transplantation ] [ Designated as safety issue: No ]
    Assessed by UPDRS


Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01446614

Contacts
Contact: Yang Xiao, MD 86-20-36653562 jdxiao111@163.com
Contact: Li Li, MD 86-20-36653562 Lily17155@yahoo.com

Locations
China, Guangdong
Guangzhou General Hospital of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Yang Xiao, MD    86-20-36653562    jdxiao111@163.com   
Contact: Li Li, MD    86-20-36654678    Lily17155@yahoo.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
Investigators
Study Director: Yang Xiao, MD Guangzhou General Hospital of Guangzhou Military Command
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01446614     History of Changes
Other Study ID Numbers: HM-2011-10
Study First Received: October 4, 2011
Last Updated: October 4, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 24, 2014