Clinical trial NCT01393977: Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China
Official title: Efficacy Difference Between Rehabilitation Therapy and Umbilical Cord Derived Mesenchymal Stem Cells Transplantation in Patients With Acute or Chronic Spinal Cord Injury in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
Stem Cell Transplantation
Rehabilitation
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The morbidity of spinal cord injury (SCI) is increasing 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, its effect to improve the neurological disorders of these patients, such as the dysfunction of sense, motor, autologous adjustment of blood pressure control of urination and defecation, perspiration , etc. is unsatisfying. 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, the investigators use mesenchymal stem cells derived from umbilical cord to treat 40 SCI patients (20 cases in early stage and 20 cases in sequela stage). The investigators also follow-up ten patients who only receive rehabilitation and another ten outpatients who accept neither stem cell therapy nor rehabilitation. On this basis, the investigators can compare the efficacy of these two treatments.

Detailed description: Patients enrolled in this study need to finish our whole follow-up survey, which is carried out by clinical doctors and epidemiologist.

Eligibility criteria: Inclusion Criteria:

1. Patients or their curator must be able to give voluntary consent.
2. Patients or their curator Must be able to understand the information of study and in which group they are.
3. 20 years - 50 years of age can be enrolled.
4. Both male and female can be enrolled.
5. Patients have clear history of traumatic injury, and the spinal cord injury are confirmed by all of the examinations including MRI, electromyogram and electrophysiology.

Exclusion Criteria:

1. Mental disorders
2. Myelitis
3. Women in pregnancy
4. Cancer

Primary outcomes:
measure: Electromyogram and Electroneurophysiologic test
timeFrame: 3 monthes after enrollment or transplantation
Secondary outcomes:
measure: Electromyogram and Electroneurophysiologic test
timeFrame: 6monthes after enrollment or transplantation
measure: Electromyogram and Electroneurophysiologic test
timeFrame: 12monthes after enrollment or transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yihua An
Study officials:
affiliation: Chinese People's Armed Police Force
name: An Yihua, doctor
role: STUDY_DIRECTOR
References:
citation: Cheng H, Liu X, Hua R, Dai G, Wang X, Gao J, An Y. Clinical observation of umbilical cord mesenchymal stem cell transplantation in treatment for sequelae of thoracolumbar spinal cord injury. J Transl Med. 2014 Sep 12;12:253. doi: 10.1186/s12967-014-0253-7.