NCT01446640

Brief Summary

The study is a phase I/II trial designed to establish the safety and efficacy of intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury.

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
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
2 days 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 3, 2011

Last Update Submit

October 4, 2011

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    1 month after transplantation

Secondary Outcomes (12)

  • Electromyogram and Electroneurophysiologic test

    1 month after transplantation

  • Muscle strength assessment

    1 month after transplantation

  • Motor and sensory assessment

    1 month after transplantation

  • Electromyogram and Electroneurophysiologic test

    3 months after transplantation

  • Muscle strength assessment

    3 months after transplantation

  • +7 more secondary outcomes

Study Arms (1)

MSC

EXPERIMENTAL

Intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury.

Biological: bone marrow derived mesenchymal stem cells

Interventions

bone marrow derived mesenchymal stem cellsBIOLOGICAL

Intravenous administration of up to 1x10\^6 MSCs per kg; intrathecal administration of up to 1x10\^6 MSCs per kg.

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

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Traumatic spinal cord injury at the thoracic or lumbar level.
  • Age 16 to 60.
  • American Spinal Injury Association Impairment Scale A or B.
  • Time between injury and enrollment greater than 2 weeks and less than 1 year.
  • Patients must have organ function as defined below:
  • total bilirubin within normal institutional limits (NV: 0.0-20.5 umol/L); AST(SGOT)/ALT(SGPT) \<2.5 × institutional upper limit of normal AST (NV: 0-35 U/L); ALT (NV: 0-40 U/L) ; Creatinine within normal institutional limits (NV: 53-106 umol/L) or Creatinine clearance \>1.25 ml/s for patients with creatinine levels above institutional normal.
  • 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.
  • Open injuries.
  • Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent.
  • Malignancy within the last 5 years.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined as invasive fungal infection and progressive CMV viremia), symptomatic congestive heart failure (NYH class III and IV), unstable angina pectoris, or cardiac arrhythmia.
  • 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)

  • Hernandez J, Torres-Espin A, Navarro X. Adult stem cell transplants for spinal cord injury repair: current state in preclinical research. Curr Stem Cell Res Ther. 2011 Sep;6(3):273-87. doi: 10.2174/157488811796575323.

    PMID: 21476980BACKGROUND

  • Paul C, Samdani AF, Betz RR, Fischer I, Neuhuber B. Grafting of human bone marrow stromal cells into spinal cord injury: a comparison of delivery methods. Spine (Phila Pa 1976). 2009 Feb 15;34(4):328-34. doi: 10.1097/BRS.0b013e31819403ce.

    PMID: 19182705BACKGROUND

  • Sheth RN, Manzano G, Li X, Levi AD. Transplantation of human bone marrow-derived stromal cells into the contused spinal cord of nude rats. J Neurosurg Spine. 2008 Feb;8(2):153-62. doi: 10.3171/SPI/2008/8/2/153.

    PMID: 18248287BACKGROUND

  • Zurita M, Vaquero J. Bone marrow stromal cells can achieve cure of chronic paraplegic rats: functional and morphological outcome one year after transplantation. Neurosci Lett. 2006 Jul 10;402(1-2):51-6. doi: 10.1016/j.neulet.2006.03.069. Epub 2006 May 19.

    PMID: 16713677BACKGROUND

  • Yoon SH, Shim YS, Park YH, Chung JK, Nam JH, Kim MO, Park HC, Park SR, Min BH, Kim EY, Choi BH, Park H, Ha Y. Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage-colony stimulating factor: Phase I/II clinical trial. Stem Cells. 2007 Aug;25(8):2066-73. doi: 10.1634/stemcells.2006-0807. Epub 2007 Apr 26.

    PMID: 17464087BACKGROUND

  • Osaka M, Honmou O, Murakami T, Nonaka T, Houkin K, Hamada H, Kocsis JD. Intravenous administration of mesenchymal stem cells derived from bone marrow after contusive spinal cord injury improves functional outcome. Brain Res. 2010 Jul 9;1343:226-35. doi: 10.1016/j.brainres.2010.05.011. Epub 2010 May 12.

    PMID: 20470759BACKGROUND

  • Hu SL, Luo HS, Li JT, Xia YZ, Li L, Zhang LJ, Meng H, Cui GY, Chen Z, Wu N, Lin JK, Zhu G, Feng H. Functional recovery in acute traumatic spinal cord injury after transplantation of human umbilical cord mesenchymal stem cells. Crit Care Med. 2010 Nov;38(11):2181-9. doi: 10.1097/CCM.0b013e3181f17c0e.

    PMID: 20711072BACKGROUND

  • Parr AM, Tator CH, Keating A. Bone marrow-derived mesenchymal stromal cells for the repair of central nervous system injury. Bone Marrow Transplant. 2007 Oct;40(7):609-19. doi: 10.1038/sj.bmt.1705757. Epub 2007 Jul 2.

    PMID: 17603514BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

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 3, 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)