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Intrathecal Stem Cells for Cerebral Palsy Phase II (ISCII)

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ClinicalTrials.gov Identifier: NCT02231242
Recruitment Status : Unknown
Verified September 2014 by Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez.
Recruitment status was:  Recruiting
First Posted : September 4, 2014
Last Update Posted : September 4, 2014
Sponsor:
Information provided by (Responsible Party):
Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary:
The purpose of this study is to determine whether the infusion of intrathecal autologous bone marrow total nucleated cells would improve the neurologic evolution of pediatric patients with quadriparetic cerebral palsy.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Biological: Autologous Stem Cell Transplantation Phase 2

Detailed Description:

There is accumulated evidence that shows that the administration of bone marrow total nucleated cells (TNC) into the brain may produce some benefits by different mechanisms like cytokine production, in several neurological areas such as motor, social, adaptative and cognitive.

It has been found that after introducing TNC in the subarachnoid space of the spinal cord, these cells may be transported through the cerebrospinal fluid and can be delivered more efficiently to the injured area, compared with intravenous route in patients with neurologic injury.

Patients will be stimulated for 3 consecutive days with subcutaneous granulocyte colony stimulating factor (G-CSF) and then their bone marrow will be harvested according to their weight. Bone marrow will be processed in order to obtain the buffy coat and minimize the amount of red blood cells. An inoculum of 10mL of this TNC will be infused intrathecally. Patients will be evaluated with the "Gross Motor Functional Classification System" before the procedure and one, three and six months after that.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Intrathecal Autologous Stem Cells for Children With Cerebral Palsy Phase II
Study Start Date : September 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intrathecal Autologous Bone Marrow TNC
Procedure/Surgery: Intrathecal Autologous Bone Marrow TNC. Other Names: Autologous Stem Cell Transplantation Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) (10mcgr/kg of body weight) for 3 consecutive days. Bone marrow will be harvested under sedation and, after being processed in the laboratory, the autologous TNC concentrate of 10 mL will be infused intrathecally.
Biological: Autologous Stem Cell Transplantation

Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) 3 consecutive days. Bone marrow will be harvested under sedation and, after being processed in the laboratory, the buffy coat (TNC) of 10 mL will be infused intrathecally.

Intrathecal Autologous Bone Marrow TNC


No Intervention: Control group
Patients will be evaluated with the "Gross Motor Functional Classification System" initially, at one, three and six months, and then cross to the intervention arm.



Primary Outcome Measures :
  1. Number of participants who show progress in GMFCS scale after autologous bonemarrow TNC intrathecal infusion. [ Time Frame: six months ]

    Patients, in an outpatient basis, will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) for 3 consecutive days. Their bone marrow will be harvested under sedation and, after being processed in the laboratory, the buffy coat of 10 mL will be infused intrathecally.

    Patient will be monitored during acute phase to register any adverse effect (malaise, headache, fever, and nausea or vomit, etc).Gross Motor Function Classification System (GMFCS) scale is going to be monitored at baseline, one, three and six months to measured differences between the scales.

    GMFCS is based on patient's self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility. Distinctions between levels are based on functional abilities, the need for assistive technology, including hand-held mobility devices (walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement.




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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with quadriplegic cerebral palsy, with an age from 7 to 9 years of age, regardless the age at the time of injury, time post-injury, or previously received therapies, different from ours

Exclusion Criteria:

  • Patients with neurodegenerative or autoimmune diseases
  • Patients with active infection in any organ or tissue at the time of entering the study, the onset of stimulation with G-CSF or at the procedure
  • Patients who do not sign the informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231242


Contacts
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Contact: Consuelo Mancias-Guerra, MD +52 81 83 48 61 36 ext 413 consuelomanciasg@gmail.com
Contact: Oscar Gonzalez-Llano, MD +52 86 75 67 18 ogzzll25@hotmail.com

Locations
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Mexico
Hematology Service, Hospital Universitario Dr. Jose E. Gonzalez Recruiting
Monterrey, Nuevo Leon, Mexico, 64460
Contact: Consuelo Mancias-Guerra, MD    +52 81 83 48 61 36 ext 413    consuelomanciasg@gmail.com   
Contact: David Gomez-Almaguer, MD    +52 81 83 48 61 36    dgomezalmaguer@gmail.com   
Principal Investigator: Consuelo Mancias-Guerra, MD         
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
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Principal Investigator: Consuelo Mancias-Guerra, MD Hospital Universitario Dr. Jose E. Gonzalez

Additional Information:
Publications:

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Responsible Party: Consuelo Mancias Guerra, Dra. Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT02231242     History of Changes
Other Study ID Numbers: HE13-004
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: September 2014

Keywords provided by Consuelo Mancias Guerra, Hospital Universitario Dr. Jose E. Gonzalez:
brain
children
cerebral palsy
bone marrow stem cells
intrathecal autologous total nucleated cells
quadriparesis

Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Sargramostim
Lenograstim
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic