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Trial record 75 of 799 for:    Interventional Studies | mesenchymal

Transplantation of Umbilical Cord-derived Mesenchymal Stem Cells Via Different Routes

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ClinicalTrials.gov Identifier: NCT03414697
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Liu Jing, The First Affiliated Hospital of Dalian Medical University

Brief Summary:
To preliminarily evaluate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSCs), and compare the efficacy of UC-MSCs administered through the intravenous, intrathecal, and intranasal routes, in the treatment of cerebral palsy in children.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Control group Procedure: UC-MSCs Not Applicable

Detailed Description:
Cerebral palsy refers to a neurological disorder caused by a non-progressive brain injury or malformation that occurs in early childhood. It can result in central motor deficits, developmental retardation, abnormal posture, abnormal muscular strength, abnormal muscle tone and/or dysreflexia. It has a high disability rate. There is currently no effective treatment for cerebral palsy. Conventional treatments for cerebral palsy are often tiresome and expensive and have a slow onset of action. Stem cells have been recently used in the treatment of cerebral palsy. This provides a novel method for the treatment of cerebral palsy. According to the existing clinical studies, neural stem cells, bone marrow-derived mesenchymal stem cells, and umbilical cord-derived mesenchymal stem cells (UC-MSCs) are mainly used as the seed cells for the treatment of cerebral palsy. UC-MSCs are the most promising seed cells for the treatment of cerebral palsy because of the advantages including rich sources, ease of harvesting, short doubling time, low immunogenicity, long-time survival post-transplantation, and no ethical issues. UC-MSCs have been widely used to treat Parkinson's disease, rheumatoid arthritis, traumatic brain injury, aplastic anemia, and decompensated liver disease. However,only two studies, and performed only in China, are reported on the treatment of cerebral palsy with UC-MSCs. One from the Hospital 463 of PLA reported 51 patients with cerebral palsy whose symptoms had not been obviously improved after 1 year of rehabilitative treatment. These patients received intrathecal injection of UC-MSCs for three times, once a week, followed by one injection of UC-MSCs via the peripheral vein in the fourth week. Four UC-MSCs injections, once per week, were considered as one course of treatment. Activities of daily living scale score was compared between before and after treatment to evaluate efficacy. Another study is a case report from China. In this report, a combined intravenous and intrathecal injection of UC-MSCs was used to treat cerebral palsy in a 5-year-old child. 28-month follow-up results revealed that the child's gross motor function, immune function, muscle strength, and language ability improved and adverse reactions were not obvious.

Study Type : Interventional
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transplantation of Umbilical Cord-derived Mesenchymal Stem Cells Via Different Routes for the Treatment of Cerebral Palsy in Children
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control group
Routine rehabilitation treatments
Other: Control group
The control group received routine rehabilitation treatments including acupuncture, massage, Bobath therapy, and Vojat therapy.

Experimental: Intravenous UC-MSCs group
Injection of UC-MSCs via the peripheral vein.
Procedure: UC-MSCs
Injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) (at least 1×10^7), once every 2 weeks, one course of treatment including two injections within 4 weeks, a total of two courses of treatment.

Experimental: Intrathecal UC-MSCs group
Injection of UC-MSCs via the intrathecal route.
Procedure: UC-MSCs
Injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) (at least 1×10^7), once every 2 weeks, one course of treatment including two injections within 4 weeks, a total of two courses of treatment.

Experimental: Intranasal UC-MSCs group
Injection of UC-MSCs via the nasal route.
Procedure: UC-MSCs
Injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) (at least 1×10^7), once every 2 weeks, one course of treatment including two injections within 4 weeks, a total of two courses of treatment.




Primary Outcome Measures :
  1. The Gross Motor Function Measure (GMFM)-88 item score [ Time Frame: 12 months after 2 courses of treatment with UC-MSCs. ]
    a 4-point scale that is divided into five categories including lying and rolling, sitting, crawling and kneeling, standing, walking, running, and jumping. A score of 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes < 10% of the activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of the activity); 3 indicates that the child completes the task (100%). The sum of score of the five categories is used as the evaluation outcome.It is used to evaluate gross motor function.


Secondary Outcome Measures :
  1. Fine Motor Function Measure scale (FMFM) score [ Time Frame: 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. ]
    To evaluate fine motor function.The scale is divided into 45 items covering visual tracing (7 items), upper extremity range of motion (8 items), grab ability (8 items), operational ability (10 items), and hand-eye coordination (12 items). The FMFM is a 4-point scale with the score range of 0-3. The original total score is 135. The summed score for evaluating fine motor function measure is 0-100.

  2. The Modified Ashworth scale (MAS) score [ Time Frame: 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. ]
    To evaluate muscle tone. The MAS score is divided into six grades: 0, 1, 1+, 2, 3 and 4. Passive full ranges of motion exercises are performed by moving the knee and ankle until the patient feel a slight resistance from hamstrings and plantar flexor muscles (soleus muscle and gastrocnemius muscle). The average score is calculated across three repeated measurements.

  3. Gesell Development Schedule score [ Time Frame: 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. ]
    To evaluate neurobehavioral development.

  4. Incidence of adverse reactions [ Time Frame: 1, 3, 6, 9 and 12 months after 2 courses of treatment with UC-MSCs. ]
    Liver and kidney dysfunction, fever, infection, vomiting.



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with hypoxic/ischemic cerebral palsy, primarily including birth asphyxia and premature children
  • Patients with spastic quadriplegia
  • Patients with moderate to severe cerebral palsy, GMFM scores of 2-3
  • Age at 2-18 years
  • Provision of signed informed consent by legal representatives of the child prior to start of the study

Exclusion Criteria:

  • Those with systemic diseases that likely interfere with the treatment or child's compliance
  • Those complicated by life-threatening diseases of any organ
  • Those with brain deformity
  • Those with uncontrolled epilepsy
  • Those with abnormal behavior or mood disorders
  • Those with allergies especially those who are allergic to blood products
  • Those are infected with infectious diseases
  • Those who had underwent a craniocerebral surgery in other clinical trials

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): NCT03414697


Contacts
Contact: Jing Liu, Ph.D 86041184394568 liujing.dlrmc@hotmail.com

Locations
China, Liaoning
The First Affiliated Hospital of Dalian Medical University Not yet recruiting
Dalian, Liaoning, China, 116011
Contact: Jing Liu, Ph.D    86041184394568    liujing.dlrmc@hotmail.com   
Sponsors and Collaborators
The First Affiliated Hospital of Dalian Medical University
Investigators
Principal Investigator: Jing Liu, Ph.D The First Affiliated Hospital of Dalian Medical University

Responsible Party: Liu Jing, Principal Investigator, The First Affiliated Hospital of Dalian Medical University
ClinicalTrials.gov Identifier: NCT03414697     History of Changes
Other Study ID Numbers: FirstHospitalDalianMU004
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liu Jing, The First Affiliated Hospital of Dalian Medical University:
umbilical cord-derived mesenchymal stem cells
cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases