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
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Nanjing University Medical College Affiliated Drum Tower Hospital | Nanjing | Jiangsu |
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 |
China,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02282826 -
A First-in-human, Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis
|
Phase 1 | |
Completed |
NCT02804594 -
A Study of Oxidative Pathways in MS Fatigue
|
Phase 2 | |
Completed |
NCT04120675 -
Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis
|
N/A | |
Completed |
NCT01719159 -
Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
|
Phase 2 | |
Enrolling by invitation |
NCT03552211 -
Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple Sclerosis
|
||
Recruiting |
NCT05740722 -
Nicotinamide Riboside Supplementation In Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT03980145 -
G-EO Gait Rehabilitation Training in Progressive Multiple Sclerosis
|
N/A | |
Completed |
NCT03269071 -
Neural Stem Cell Transplantation in Multiple Sclerosis Patients
|
Phase 1 | |
Not yet recruiting |
NCT05811013 -
Effects of Transcranial Static Magnetic Field Stimulation (tSMS) in Progressive Multiple Sclerosis
|
N/A | |
Not yet recruiting |
NCT04289909 -
Identification of Retinal Perivascular Inflammation in Patients With Multiple Sclerosis Using Adaptive Optics (RETIMUS)
|
N/A | |
Recruiting |
NCT05685784 -
Multiple Sclerosis Prediction and Monitoring of Progression Study
|
N/A | |
Completed |
NCT03493841 -
Comparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple Sclerosis
|
Phase 1 | |
Completed |
NCT03302806 -
Study to Assess Effect and Safety of High Dose of Biotin (Qizenday®) in Progressive Multiple Sclerosis
|
||
Recruiting |
NCT05441488 -
Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis
|
Phase 3 | |
Recruiting |
NCT04695080 -
ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis
|
Phase 2/Phase 3 | |
Recruiting |
NCT06451159 -
A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis
|
Phase 1 | |
Completed |
NCT03423121 -
A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Terminated |
NCT02580669 -
Study by Magnetic Resonance Imaging in the Progressive Forms of Multiple Sclerosis
|
N/A | |
Enrolling by invitation |
NCT05706220 -
Visual Processing Speed and Objective Analysis of Ocular Movements in Multiple Sclerosis
|
||
Recruiting |
NCT01815632 -
Assessment of Bone Marrow-derived Cellular Therapy in Progressive Multiple Sclerosis (ACTiMuS)
|
Phase 2 |