Safety and Efficacy Study of Autologus Bone Marrow Mesenchymal Stem Ce
Phase II Study: Use of Autologus Mesenchymal Stem Cells in Multiple Sclerosis Patients Who do Not Respond to Conventional Treatment
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Autologous Mesenchymal Stem Cells
What it measured
Main measures
The number of patients with any relevant side effects observed
18 months
Safety
Other measures (1)
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Magnetic Resonance Imaging (MRI) and ophthalmological tests.
18 months
MRI lesions
Who could take part
MS (type not specified) · 18 to 65
Show the full criteria
Inclusion criteria
* A clinical diagnosis of definite MS according to the revised McDonald Criteria. * Expanded Disability Status Scale (EDSS) ≤ 6 * Failure of standard medical therapy * Disease duration of at least three years prior to enrollment.
Exclusion criteria
* Pregnant and lactating women * Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment * Recent MS relapse in the month prior to enrollment * Treatment with oral or parenteral steroids for any cause in the month prior to enrollment * Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders * Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment * Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast. * Positive serology for HIV, Hepatitis B or Hepatitis C * Any history of malignancy or exposure to radiation at any time prior to enrollment * Any contra-indication to lumbar puncture * Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
1. Expanding and priming Bone Marrow (BM)- Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice using xenogenic free media instead of the previously used FCS. 2. Assessing the safety of injecting autologous BM-MSCs to Multiple Sclerosis (MS)patients who fail to respond to conventional treatment. 3. Assessing the therapeutic benefits on the participants in the trial as per established methods.
Papers
Loading reviews and guidelines…
Related trials
- A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory
Phase 1 · Not yet recruiting
Still running
- A Study of C-CAR168 in the Treatment of Central Nervous System Autoimm
Phase 1 · Not yet recruiting
Still running
- Autologous CD19/BCMA Dual-Target CAR-T for Relapsed/Refractory Autoimm
Phase 1 · Withdrawn
Stopped
- Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases
Early phase 1 · Not yet recruiting
Still running
- A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory
Phase 1 · Recruiting
Still running
- Neurofilament Light Chain ,Chitinase-3 Like-1 Proteins and Plasmacytoi
Status unknown
No results found
History
Started
Oct 2012
Main results due
Feb 2016
Finished
Feb 2016