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

Beike Biotech

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Neuromyelitis Optica.; Progressive Multiple Sclerosis

Treatments: Biological: human umbilical cord mesenchymal stem cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01364246

BKCR-MS-1.0(2010)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Human umbilical cord mesenchymal stem cells transplantation

Experimental group

Description:

Intervention group

Treatment:

Biological: human umbilical cord mesenchymal stem cells