Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China

NCT01873547 | Completed Phase 3 DMC

• 1 other identifier: 2013-03-04SCI-III
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The morbidity of spinal cord injury (SCI) is increasing year by year significantly in China. The methods to treat SCI patients in sequela stage update are poor. Though traditional rehabilitation therapy is the routine method to treat SCI in sequela stage, aiming to improve the neurological disorders of these patients, such as sensory disturbance, dyskinesia, autologous adjustment of blood pressure, dysfunction of urination, defecation and perspiration , etc. What's a pity, the efficacy of the rehabilitation therapy is unsatisfactory. Rehabilitation Therapy can prevent the process of muscle atrophy and joint stiffness. However, it can not repair the damaged nerve function. Studies show that mesenchymal stem cell transplantation can remarkably improve the neurological function of SCI in animals without any severe side effect. In this study, 300 patients will be divided into three groups and the investigators will use mesenchymal stem cells derived from umbilical cord to treat 100 SCI patients. They will also follow up 100 patients who only receive rehabilitation and another 100 patients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; cell transplantation; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Assessment of changes in International Standards for Neurological Classification of Spinal Cord Injury according to American Spine Injury Association

  ASIA is American Spine Injury Association.The ASIA publishes the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), which is a neurological exam widely used to document sensory and motor impairments following spinal cord injury (SCI). The ASIA assessment is the gold standard for assessing SCI. The exam is based on neurological responses, touch and pinprick sensations tested in each dermatome, and strength of the muscles that control key motions on both sides of the body. Muscle strength is scored on a scale of 0-5 according to the adjacent table, and sensation is graded on a scale of 0-2: 0 is no sensation, 1 is altered or decreased sensation, and 2 is full sensation. Each side of the body is graded independently. The ISNCSCI exam is used for determining the neurological level of injury. ASIA Impairment Scale for classifying spinal cord injury includes five grades: A, B, C, D and E.

  Baseline, 6 and 12 months after recruitment

Secondary Outcomes (3)

• Assessment of changes in score of pain index using Short-form McGill Pain Questionnaire

  Baseline,6 and 12 months after recruitment

• Assessment of changes in score of activity of daily living

  Baseline, 6 and 12 months after recruitment

• Assessment of changes in sensory evoked potentials and motor evoked potentials

  Baseline,6 and 12 months after recruitment

Study Arms (3)

rehabilitation

ACTIVE COMPARATOR

Patients in the group accept rehabilitation for three weeks in hospital and other eleven months in their home under the guidance of physical therapist.

Other: rehabilitation

cell therapy

EXPERIMENTAL

Patients in the group accept cell therapy including four times stem cells transplant via intrathecal injection.

Biological: cell therapy

control

NO INTERVENTION

Patients receive no professional treatment in hospital or rehabilitation centre.

Interventions

cell therapy BIOLOGICAL

Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.

cell therapy

rehabilitation OTHER

Patients only receive rehabilitation of limb function.

Also known as: physical exercise rehabilitation

rehabilitation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients or their curator must be able to give voluntary consent.
• Patients have clear history of traumatic injury.
• years - 65 years of age can be enrolled.
• Both male and female can be enrolled.
• The diagnosis of spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.
• The time of injury was longer than 1 year.

You may not qualify if:

• Mental disorders
• Myelitis
• Women in pregnancy
• Cancer

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead

Study Sites (1)

General Hospital of Chinese People's Armed Police Forces

Beijing, Beijing Municipality, 100050, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Cell- and Tissue-Based Therapy; Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yihua An, Ph.D

  the General Hospital of Chinese People's Armed Police Forces

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cell therapy or rehabitation treatment

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 10, 2013
• Study Start: June 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 25, 2018

Record last verified: 2018-05

Locations

CN (1)