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Spinal Cord InjuryPhase 1/2MSCNCT01446640

Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury

A Phase 1/2 study testing bone marrow derived mesenchymal stem cells in people with Spinal Cord Injury, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Spinal Cord Injury
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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

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.
  • Open injuries.
  • Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent.
  • Malignancy within the last 5 years.
Show all 9Show fewer
  • 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.

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 Spinal Cord Injury.

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.

Read the detailed description

Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis. Pharmacological and rehabilitation therapies to SCI get limited effect. Another promising therapeutic approaches for SCI is cellular transplantation. Cell types used in SCI therapy include Schwann cells, olfactory ensheathing cells and adult stem cells, such as neural stem cells, umbilical cord blood derived cells, mesenchymal stem cells (MSCs) or induced pluripotent stem cells. There are not yet conclusive evidences on which types of glial or adult stem cells are most effective in SCI treatment.

MSC have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing ,axonal regeneration, and remyelination. Therapeutic effects of MSCs are primarily due to the secretion of soluble factors and the provision of extracellular matrix that provide protection and support repair. MSC are attractive candidates for transplantation into human patients because they can be easily harvested, expanded and banked, or derived directly from the patient allowing for autologous transplantation, obviating the need for immune suppression.

The clinical translation of cellular transplantation strategies requires a safe and efficient means of cellular delivery. In animal models of SCI, the most common delivery is direct injection into the injury site, which allows a defined number of cells to be delivered, but risks further injuring the cord. Less invasive methods for cell delivery have been investigated, including intravascular delivery (intravenous (IV) and intra-arterial) and delivery into the cerebrospinal fluid (intrathecal). These minimally-invasive techniques decrease the risk to the patient and allow delivery of multiple cell doses. Maybe intrathecal administration is superior to IV delivery, cell engraftment and tissue sparing were significantly better after intrathecal delivery, but more researches are needed for get conclusion.

Being tested
bone marrow derived mesenchymal stem cells
Medical subject headings
Spinal Cord Injuries

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

Study groups in NCT01446640
Study groupRoleWhat they receive
MSCExperimentalIntravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury.
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 (12)

  1. Electromyogram and Electroneurophysiologic test

    somatosensory and motor evoked potentials

    Measured: 1 month after transplantation

  2. Muscle strength assessment

    Assessed by the Frankel scale.

    Measured: 1 month after transplantation

  3. Motor and sensory assessment

    Assessed by ASIA score

    Measured: 1 month after transplantation

  4. Electromyogram and Electroneurophysiologic test

    somatosensory and motor evoked potentials

    Measured: 3 months after transplantation

  5. Muscle strength assessment

    Assessed by the Frankel scale.

    Measured: 3 months after transplantation

  6. Motor and sensory assessment

    Assessed by ASIA score

    Measured: 3 months after transplantation

  7. Electromyogram and Electroneurophysiologic test

    somatosensory and motor evoked potentials

    Measured: 6 months after transplantation

  8. Muscle strength assessment

    Assessed by the Frankel scale.

    Measured: 6 months after transplantation

  9. Motor and sensory assessment

    Assessed by ASIA score

    Measured: 6 months after transplantation

  10. Electromyogram and Electroneurophysiologic test

    somatosensory and motor evoked potentials

    Measured: 12 months after transplantation

  11. Muscle strength assessment

    Assessed by the Frankel scale.

    Measured: 12 months after transplantation

  12. Motor and sensory assessment

    Assessed by ASIA score

    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
NCT01446640
Sponsor's protocol ID
HM-2011-09
Acronym
MSC
Status last verified
Oct 2011
First submitted
3 Oct 2011
Last updated
5 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21476980

  • 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.

    PubMed 19182705

  • 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.

    PubMed 18248287

  • 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.

    PubMed 16713677

  • 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.

    PubMed 17464087

  • 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.

    PubMed 20470759

  • 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.

    PubMed 20711072

  • 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.

    PubMed 17603514

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 Spinal Cord Injury, 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 9 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 NCT01446640, 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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