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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Routine rehabilitation treatments

Group Type OTHER

Control group

Intervention Type OTHER

The control group received routine rehabilitation treatments including acupuncture, massage, Bobath therapy, and Vojat therapy.

Intravenous UC-MSCs group

Injection of UC-MSCs via the peripheral vein.

Group Type EXPERIMENTAL

UC-MSCs

Intervention Type PROCEDURE

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.

Intrathecal UC-MSCs group

Injection of UC-MSCs via the intrathecal route.

Group Type EXPERIMENTAL

UC-MSCs

Intervention Type PROCEDURE

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.

Intranasal UC-MSCs group

Injection of UC-MSCs via the nasal route.

Group Type EXPERIMENTAL

UC-MSCs

Intervention Type PROCEDURE

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.

Interventions

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Control group

The control group received routine rehabilitation treatments including acupuncture, massage, Bobath therapy, and Vojat therapy.

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No