Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Status and phase: Completed; Phase 2; Phase 1

Conditions: Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Immune System Diseases; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases

Treatments: Other: Autologous mesenchymal stem cells from adipose tissue.

Study type: Interventional

Funder types: Other

Identifiers

NCT01056471

CMM/EM/2008

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

30 participants in 3 patient groups

Low dose autologous mesenchymal cells

Experimental group

Description:

The dose of infused cells is 10e6 cells/Kg

Treatment:

Other: Autologous mesenchymal stem cells from adipose tissue.

Other: Autologous mesenchymal stem cells from adipose tissue.

High dose

Experimental group

Description:

The dose of infused cells is 4\*10e6 cells/Kg

Treatment:

Other: Autologous mesenchymal stem cells from adipose tissue.

Other: Autologous mesenchymal stem cells from adipose tissue.

Placebo Control

No Intervention group