NCT01446614

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

1.7 years

First QC Date

October 4, 2011

Last Update Submit

October 4, 2011

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    1 month after transplantation

Secondary Outcomes (4)

  • Effect assessment

    1 month after transplantation

  • Effect assessment

    3 months after transplantation

  • Effect assessment

    6 months after transplantation

  • Effect assessment

    12 months after transplantation

Study Arms (1)

MSC

EXPERIMENTAL

Intravenous autologous bone marrow derived mesenchymal stem cells infusion to patients with Parkinson's disease.

Biological: bone marrow derived mesenchymal stem cells

Interventions

bone marrow derived mesenchymal stem cellsBIOLOGICAL

Intravenous administration of up to 6x10\^5 MSCs per kg,qw,for 4 weeks

Also known as: Mesenchymal Stem Cells, Multipotent Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal Cells
MSC

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510010, China

RECRUITING

Related Publications (8)

  • Wang Y, Chen S, Yang D, Le WD. Stem cell transplantation: a promising therapy for Parkinson's disease. J Neuroimmune Pharmacol. 2007 Sep;2(3):243-50. doi: 10.1007/s11481-007-9074-2. Epub 2007 May 9.

    PMID: 18040857BACKGROUND

  • Karussis D, Kassis I, Kurkalli BG, Slavin S. Immunomodulation and neuroprotection with mesenchymal bone marrow stem cells (MSCs): a proposed treatment for multiple sclerosis and other neuroimmunological/neurodegenerative diseases. J Neurol Sci. 2008 Feb 15;265(1-2):131-5. doi: 10.1016/j.jns.2007.05.005. Epub 2007 Jul 3.

    PMID: 17610906BACKGROUND

  • Schwarz J, Storch A. Transplantation in Parkinson's disease: will mesenchymal stem cells help to reenter the clinical arena? Transl Res. 2010 Feb;155(2):55-6. doi: 10.1016/j.trsl.2009.08.008. Epub 2009 Sep 19. No abstract available.

    PMID: 20129484BACKGROUND

  • Glavaski-Joksimovic A, Virag T, Mangatu TA, McGrogan M, Wang XS, Bohn MC. Glial cell line-derived neurotrophic factor-secreting genetically modified human bone marrow-derived mesenchymal stem cells promote recovery in a rat model of Parkinson's disease. J Neurosci Res. 2010 Sep;88(12):2669-81. doi: 10.1002/jnr.22435.

    PMID: 20544825BACKGROUND

  • Somoza R, Juri C, Baes M, Wyneken U, Rubio FJ. Intranigral transplantation of epigenetically induced BDNF-secreting human mesenchymal stem cells: implications for cell-based therapies in Parkinson's disease. Biol Blood Marrow Transplant. 2010 Nov;16(11):1530-40. doi: 10.1016/j.bbmt.2010.06.006. Epub 2010 Jun 10.

    PMID: 20542127BACKGROUND

  • Shetty P, Ravindran G, Sarang S, Thakur AM, Rao HS, Viswanathan C. Clinical grade mesenchymal stem cells transdifferentiated under xenofree conditions alleviates motor deficiencies in a rat model of Parkinson's disease. Cell Biol Int. 2009 Aug;33(8):830-8. doi: 10.1016/j.cellbi.2009.05.002. Epub 2009 May 22.

    PMID: 19465139BACKGROUND

  • Zhang Z, Wang X, Wang S. Isolation and characterization of mesenchymal stem cells derived from bone marrow of patients with Parkinson's disease. In Vitro Cell Dev Biol Anim. 2008 May-Jun;44(5-6):169-77. doi: 10.1007/s11626-008-9093-1. Epub 2008 Apr 10.

    PMID: 18401666BACKGROUND

  • Park HJ, Lee PH, Bang OY, Lee G, Ahn YH. Mesenchymal stem cells therapy exerts neuroprotection in a progressive animal model of Parkinson's disease. J Neurochem. 2008 Oct;107(1):141-51. doi: 10.1111/j.1471-4159.2008.05589.x. Epub 2008 Jul 28.

    PMID: 18665911BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Yang Xiao, MD

    Guangzhou General Hospital of Guangzhou Military Command

    STUDY DIRECTOR

Central Study Contacts

Yang Xiao, MD

CONTACT

86-20-36653562jdxiao111@163.com

Li Li, MD

CONTACT

86-20-36653562Lily17155@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2011

First Posted

October 5, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

CN(1)