Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

Progressive Multiple Sclerosis Clinical Trial

Official title:

Phase I/II Study of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Progressive Multiple Sclerosis and Neuromyelitis Optica

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01364246
• Other study ID #: BKCR-MS-1.0(2010)
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 31, 2011
• Last updated: November 26, 2012
• Start date: January 2010
• Est. completion date: December 2014

Study information

• Verified date: November 2012
• Source: Shenzhen Beike Bio-Technology Co., Ltd.
• Contact: Yun Yun Xu
• Email: xuyun20042001[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Multiple sclerosis (MS) has been classically regarded as a chronic inflammatory autoimmune demyelinating disease of the central nervous system, along with a considerable pathological heterogeneity. Neuromyelitis optica (NMO) is a severe inflammatory, demyelinating disease, and its clinical characteristics include recurrent optic neuritis and longitudinally extensive transverse myelitis.

Current therapies provide only modest control of progressive Multiple Sclerosis and Neuromyelitis Optica.Stem cell therapy might open a light horizon in approaching to an efficient treatment in progressive MS and NMO. In this study, the safety and efficacy of Human Umbilical Cord Mesenchymal Stem Cells transplantation will be evaluated in patients with progressive MS and NMO.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• McDonald Diagnosis of Multiple Sclerosis or 2006 Diagnosis of neuromyelitis optica.

• Aged 16-65 years.

• Disease duration=2years

• Poor response to steroid therapy.

• Written informed consent and follow the clinic trail procedure

Exclusion Criteria:

• Cardiac insufficiency; Renal insufficiency; hepatic insufficiency; Total bilirubin higher than 1.5 times of upper limit of normal value; AST /ALT higher than 2.5 times of upper limit of normal value.

• Combined Pneumonia or other Severe systemic bacteria infection.

• Severe drug allergic history or anaphylaxis to 2 or more food or medicine.

• Intracranial hypertension dues to Other brain lesions (eg. Brain cancer)/

• HIV+, TPPA +, patients diagnosed as HBV or HCV.

• Tumor Markers +

• Severe psychotic patients, cognitive dysfunction,Or can not understand or sign the Consent Form.

• Coagulation disorders.

• Uncontrolled hypertension after treatment,blood pressure=180mmHg/110 mmHg.

• Pregnancy.

• Enrollment in other trials in the last 3 months.

• Other criteria the investigator consider improper for inclusion.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuromyelitis Optica
• Neuromyelitis Optica.
• Progressive Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• human umbilical cord mesenchymal stem cells
Participants will be given hUC-MSCs transplantation.

Locations

Country	Name	City	State
China	Nanjing University Medical College Affiliated Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (6)

Lead Sponsor	Collaborator
Shenzhen Beike Bio-Technology Co., Ltd.	Nanjing University Medical College Affiliated Wuxi Second Hospital, The Affiliated Nanjing Brain Hospital of Nanjing University Medical School, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Second Hospital of Nanjing Medical University, Xuzhou Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of Expanded Disability Status Scale (EDSS)		1 year after treatment	No
Secondary	Visual Evoked Potential (VEP)		1 year after treatment	No
Secondary	Brainstem Auditory Evoked Potential (BAEP)		1 year after treatment	No
Secondary	Somatosensory Evoked Potential(SEP)		1 year after treatment	No
Secondary	Brain Magnetic Resonance Imaging (MRI) Scan		1 year after treatment	No