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Parkinson's DiseasePhase 1/2NCT01446614

Mesenchymal Stem Cells Transplantation to Patients With Parkinson's Disease

A Phase 1/2 study testing bone marrow derived mesenchymal stem cells in people with Parkinson's Disease, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Parkinson's Disease
What is being tested?
bone marrow derived mesenchymal stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Oct 2011to Jun 2014
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Yang Xiao, MD contact

86-20-36653562

jdxiao111@163.com

Li Li, MD contact

86-20-36653562

Lily17155@yahoo.com

China1 site, 1 recruiting

  • Guangzhou General Hospital of Guangzhou Military Command

    Guangzhou, Guangdong, 510010

    Yang Xiao, MD, 86-20-36653562, jdxiao111@163.com

    Li Li, MD, 86-20-36654678, Lily17155@yahoo.com

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
bone marrow derived mesenchymal stem cells
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bone marrow derived mesenchymal stem cellsBiological

    Also called Mesenchymal Stem Cells, Multipotent Mesenchymal Stem Cells, Multipotent Mesenchymal Stromal Cells

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

Study groups in NCT01446614
Study groupRoleWhat they receive
MSCExperimentalIntravenous autologous bone marrow derived mesenchymal stem cells infusion to patients with Parkinson's disease.
Receives: Biological: bone marrow derived mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events

    Measured: 1 month after transplantation

Secondary outcomes (4)

  1. Effect assessment

    Assessed by Unified Parkinson's Disease Rating Scale (UPDRS).

    Measured: 1 month after transplantation

  2. Effect assessment

    Assessed by UPDRS

    Measured: 3 months after transplantation

  3. Effect assessment

    Assessed by UPDRS

    Measured: 6 months after transplantation

  4. Effect assessment

    Assessed by UPDRS

    Measured: 12 months after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJun 2013 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01446614
Sponsor's protocol ID
HM-2011-10
Status last verified
Oct 2011
First submitted
4 Oct 2011
Last updated
5 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18040857

  • 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.

    PubMed 17610906

  • 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.

    PubMed 20129484

  • 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.

    PubMed 20544825

  • 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.

    PubMed 20542127

  • 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.

    PubMed 19465139

  • 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.

    PubMed 18401666

  • 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.

    PubMed 18665911

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bone marrow derived mesenchymal stem cells in people with Parkinson's Disease, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yang Xiao, MD (86-20-36653562, jdxiao111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 1 month after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01446614, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.

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