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

NCT02482194 | Completed Phase 1 DMC

• 1 other identifier: AFBMTC-SCI-2013
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spinal Cord Injury

Keywords

Spinal cord injury; mesenchymal stem cells; transplantation

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

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

  1 month

Secondary Outcomes (3)

• Sensory and motor strength

  1 year

• Functional Independence

  1 year

• Muscle strength assessment

  1 year

Study Arms (1)

Autologous mesenchymal stem cells

EXPERIMENTAL

use of mesenchymal stem cells as therapeutic intervention for spinal cord injury patients by autologous transplantation

Biological: mesenchymal stem cells

Interventions

mesenchymal stem cells BIOLOGICAL

autologous transplantation of mesenchymal stem cells in spinal cord injury patients

Also known as: MSC

Autologous mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Axonic brain injury
• Inability to provide consent
• Open injuries
• Active infectious diseases
• Terminal patients
• Neurodegenerative diseases
• 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.

Sponsors & Collaborators

• National Institute of Blood and Marrow Transplant (NIBMT), Pakistan: lead
• Armed Forces Institute of Regenerative Medicine: collaborator

Study Sites (1)

Armed Forces Bone Marrow Transplant Centre

Rawalpindi, 46000, Pakistan

Location

Related Publications (9)

• 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.

  PMID: 11922856 BACKGROUND

• 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.

  PMID: 19394407 BACKGROUND

• 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.

  PMID: 20832402 BACKGROUND

• 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: 21476980 BACKGROUND

• 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.

  PMID: 20146557 BACKGROUND

• 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.

  PMID: 22464434 BACKGROUND

• 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.

  PMID: 24772239 BACKGROUND

• 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.

  PMID: 25635918 BACKGROUND

• 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.

  PMID: 26971680 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Parvez Ahmed

  Commandant Armed Forces Bone Marrow Transplant Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 26, 2015
• Study Start: June 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

PA (1)