Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With
Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to 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 from adipose tissue.
What it measured
Main measures
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
12 months.
Safety
Other measures (1)
To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales.
12 months
Nerve conduction testsQuality of life (reported by participants)
Who could take part
Progressive MS · 18 and over
Show the full criteria
Inclusion criteria
1. Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria). 2. Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9. 3. Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression. 4. Patients with no MS relapse and no steroid treatment within the month prior to inclusion. 5. Patients who give written consent to participate in the study. -
Exclusion criteria
1. History of current pathology or current laboratory results indicative of any severe disease. 2. Pacemaker or metallic implants that prevent MR imaging. 3. Inability to complete questionnaires. 4. Refusal to give informed consent. 5. Predicted impossibility for a biopsy of at least 30 grams of fat tissue. 6. Positive screening test for HIV, Hepatitis B or Hepatitis C. 7. History of malignancy. 8. Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline. 9. Body mass index> 40 kg/m2. 10. Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study. 11. Pregnancy or lactation -
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.
Papers
Loading reviews and guidelines…
Related trials
- C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cel
Phase 1 / Phase 2 · Not yet recruiting
Still running
- A Phase IIa Study of Vitamin D3 Tolerogenic Dendritic Cells (tolDC) fo
Phase 2 · Not yet recruiting
Still running
- Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
Phase 2 · Not yet recruiting
Still running
- Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
Phase 1 · Recruiting
Still running
- Allogenic Adipose Tissue-derived Mesenchymal Stromal Cells for the Tre
Phase 1 · Recruiting
Still running
- Nasal Foralumab in Patients With Non-Active Secondary Progressive Mult
Phase 2 · Recruiting
Still running
History
Started
Jan 2010
Main results due
Jun 2012
Finished
Jun 2015