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Spinal Cord InjuryPhase 1NCT02482194

Autologous Mesenchymal Stem Cells Transplantation for Spinal Cord Injury- A Phase I Clinical Study

A Phase 1 study testing mesenchymal stem cells in people with Spinal Cord Injury, run by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The conventional treatment of spinal cord injury (SCI) includes physical therapy and rehabilitation and in some cases may require surgical intervention. Although improved emergency care and aggressive treatment can help in preventing further damage and even restore minimal sensory functions, still a large proportion… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
mesenchymal stem cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 sitePakistan
Study dates
Jun 2013to Mar 2016
Phase
Phase 1
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 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients suffering from sub-acute and chronic phase of spinal cord injury
  • Traumatic spinal cord injury at the thoracic level
  • American Spinal Injury Association (ASIA) impairment scale "A"
  • Confirmation by MRI of injury level
  • Time between injury and enrollment greater than 2 weeks
  • Ability to provide informed consent

Who cannot join

  • Axonic brain injury
  • Inability to provide consent
  • Open injuries
  • Active infectious diseases
  • Terminal patients
  • Neurodegenerative diseases
Show all 13Show fewer
  • Evidence of meningitis
  • Cerebral palsy
  • Primary haematologic diseases
  • Coagulopathies
  • Pregnancy
  • Other medical complications that contra-indicate surgery, including major respiratory complications
  • Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Armed Forces Bone Marrow Transplant Centre

    Rawalpindi, 46000

Other trials in Pakistan

About this study

Official title: Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells in Patients of Spinal Cord Injury-Phase I Clinical Trial

The conventional treatment of spinal cord injury (SCI) includes physical therapy and rehabilitation and in some cases may require surgical intervention. Although improved emergency care and aggressive treatment can help in preventing further damage and even restore minimal sensory functions, still a large proportion of patients suffer with prolonged disabilities. It led neurologists to search out for new treatment options for this otherwise debilitating disorder. Recent advances in research have developed a better understanding of stem cell biology especially their role in tissue repair and regeneration. Encouraging results in pre-clinical phase and limited human trials have proved that stem cells can be safely and effectively delivered to the injured site for regeneration of damaged tissue. Although a variety of cell types have been tried for their role in repair of spinal cord injury, majority of clinical trials employed stem cells taken from bone marrow especially mesenchymal stromal cells (MSC). Bone marrow MSCs are a good choice for regenerative therapies owing to advantages like ease of collection and ex-vivo culturing, immune tolerance and their ability to differentiate into a variety of cell types including neuronal lineage cells. Intravenous application or direct injection of MSCs into cerebrospinal fluid (CSF) via lumber puncture in animal models of SCI and brain trauma had shown that MSCs can migrate towards and integrate into injured spinal tissue and reduce cyst size and increase functional recovery. The literature indicates that acute, sub-acute and chronic injury can be a therapeutic target for MSC grafting. The mechanism of action may however vary among these conditions. In acute phase, MSC administration play anti-inflammatory role, while in sub-acute/chronic setting it may be used as neurostimulator and for cell bridging effect and possibly glial or neuronal cell replacement. The investigators propose a non-randomized, single group, open label, phase-I, interventional study to evaluate the safety and efficacy of intrathecal delivery of patient's own (autologous) bone marrow mesenchymal stem cells for treatment of spinal cord injury. This will include determination of functional recovery (neuro-muscular control and sensation) in the affected area and overall improvement in quality of life of the patients and also take into account any side effects, if observed.

Read the detailed description

The role of regenerative therapies has gained more importance due to increased number of SCI in the wake of recent anti-terrorism operations by the armed forces and non-availability of any curative treatment for this category of patients. The promising results of preliminary clinical trials have proved that adult stem cells especially multipotent mesenchymal stromal cells can be safely injected and well tolerated and have shown functional improvement in SCI patients. The successful treatment in these patients will not only improve functional status of these otherwise debilitating patients, but can also reduce the burden on health care facilities. Mesenchymal stem cells 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. In this study patients suffering from sub-acute and chronic phase of spinal cord injury shall be included. Patients will undergo detailed screening through MRI and motor and sensory assessment by ASIA score. Further evaluation will include electromyography (EMG) and tests for electroneurophysiological assessment like nerve conduction velocity (NCV) will also be done. Bone marrow aspiration will be done from iliac crest of the patients, followed by mononuclear cells (MNCs) separation by density gradient centrifugation. MNCs will be washed and cultured in tissue culture flasks. After 48 hours non-adherent cells will be removed from culture. Medium will be changed twice weekly till MSCs reach 70-80 % confluence. At that point MSCs will be harvested and after microbiological and other quality control testing the cellular preparation will be diluted to final concentration and infused by intrathecal injection.

Primary outcome measure is safety which will be determined by clinical evaluation by two independent neurologists during one month of hospital stay after receiving treatment course.

Secondary outcome measures will include American Spinal Injury Association (ASIA) impairment scale and NCV/EMG.

Being tested
mesenchymal stem cells
Keywords
Spinal cord injury, mesenchymal stem cells, transplantation
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.

  • mesenchymal stem cellsBiological

    Also called MSC

    autologous transplantation of mesenchymal stem cells in spinal cord injury patients

Study groups in NCT02482194
Study groupRoleWhat they receive
Autologous mesenchymal stem cellsExperimentaluse of mesenchymal stem cells as therapeutic intervention for spinal cord injury patients by autologous transplantation
Receives: Biological: mesenchymal stem cells

What is being measured

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

  1. Number of adverse events

    Number of adverse events occurring in given time frame shall be reported to evaluate overall safety of the procedure

    Measured: 1 month

Secondary outcomes (3)

  1. Sensory and motor strength

    Improvement in sensitivity and motor strength will be measured through change in American Spinal Injury Association (ASIA) score from baseline

    Measured: 1 year

  2. Functional Independence

    Functional Independence will be measured by FIM scoring

    Measured: 1 year

  3. Muscle strength assessment

    Shall be done using Frankel scale

    Measured: 1 year

Timeline

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

  1. First posted26 Jun 2015 (estimated)
  2. Study startJun 2013
  3. Primary completionJan 2016
  4. Study completionMar 2016

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02482194
Sponsor's protocol ID
AFBMTC-SCI-2013
Status last verified
Jun 2016
First submitted
18 Jun 2015
Last updated
29 Jun 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Legos JJ, Gopez JJ, Young WF. Non-surgical management of spinal cord injury. Expert Opin Investig Drugs. 2002 Apr;11(4):469-82. doi: 10.1517/13543784.11.4.469.

    PubMed 11922856

  • Zhang HT, Cheng HY, Cai YQ, Ma X, Liu WP, Yan ZJ, Jiang XD, Xu RX. Comparison of adult neurospheres derived from different origins for treatment of rat spinal cord injury. Neurosci Lett. 2009 Jul 24;458(3):116-21. doi: 10.1016/j.neulet.2009.04.045. Epub 2009 Apr 24.

    PubMed 19394407

  • Mackay-Sim A, St John JA. Olfactory ensheathing cells from the nose: clinical application in human spinal cord injuries. Exp Neurol. 2011 May;229(1):174-80. doi: 10.1016/j.expneurol.2010.08.025. Epub 2010 Sep 9.

    PubMed 20832402

  • 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

  • Tetzlaff W, Okon EB, Karimi-Abdolrezaee S, Hill CE, Sparling JS, Plemel JR, Plunet WT, Tsai EC, Baptiste D, Smithson LJ, Kawaja MD, Fehlings MG, Kwon BK. A systematic review of cellular transplantation therapies for spinal cord injury. J Neurotrauma. 2011 Aug;28(8):1611-82. doi: 10.1089/neu.2009.1177. Epub 2010 Apr 20.

    PubMed 20146557

  • Karamouzian S, Nematollahi-Mahani SN, Nakhaee N, Eskandary H. Clinical safety and primary efficacy of bone marrow mesenchymal cell transplantation in subacute spinal cord injured patients. Clin Neurol Neurosurg. 2012 Sep;114(7):935-9. doi: 10.1016/j.clineuro.2012.02.003. Epub 2012 Mar 30.

    PubMed 22464434

  • Dasari VR, Veeravalli KK, Dinh DH. Mesenchymal stem cells in the treatment of spinal cord injuries: A review. World J Stem Cells. 2014 Apr 26;6(2):120-33. doi: 10.4252/wjsc.v6.i2.120.

    PubMed 24772239

  • All AH, Gharibani P, Gupta S, Bazley FA, Pashai N, Chou BK, Shah S, Resar LM, Cheng L, Gearhart JD, Kerr CL. Early intervention for spinal cord injury with human induced pluripotent stem cells oligodendrocyte progenitors. PLoS One. 2015 Jan 30;10(1):e0116933. doi: 10.1371/journal.pone.0116933. eCollection 2015.

    PubMed 25635918

  • Satti HS, Waheed A, Ahmed P, Ahmed K, Akram Z, Aziz T, Satti TM, Shahbaz N, Khan MA, Malik SA. Autologous mesenchymal stromal cell transplantation for spinal cord injury: A Phase I pilot study. Cytotherapy. 2016 Apr;18(4):518-22. doi: 10.1016/j.jcyt.2016.01.004.

    PubMed 26971680

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing mesenchymal stem cells in people with Spinal Cord Injury, run by National Institute of Blood and Marrow Transplant (NIBMT), Pakistan at 1 site in Pakistan.

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 6 inclusion and 13 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: finished, as of the sponsor's last update on 29 Jun 2016. 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 Pakistan. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (time frame: 1 month). 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 NCT02482194, which also lists 9 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 29 Jun 2016.

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