Multi-Center Study Safety of Adipose Derived Mesenchymal Stem Cells fo
Proposal for a Non-randomized, Patient Sponsored, Multi-center Study Studying the Impact and Safety of the Utilization of Culture Expanded Autologous, Adipose-derived Mesenchymal Stem Cells Deployed Via Intravenous Injection for the Treatment of Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Autologous adipose derived mesenchymal cells
What it measured
Main measures
Standard Complication Questionnaire
3 months
SafetyMS Impact Scale - MSIS-29
3 months
Quality of life (reported by participants)Modified SF-36 Cell-Based Therapy Follow Up
3 months
Quality of life (reported by participants)Physical Evaluation
3 Months
Safety
Other measures (11)
MS Impact Scale - MSIS-29
6 months
Quality of life (reported by participants)MS Impact Scale - MSIS-29
1 year
Quality of life (reported by participants)Modified SF-36 Cell-Based Therapy Follow Up
6 months
Quality of life (reported by participants)Standard Complication Questionnaire
6 months
SafetyStandard Complication Questionnaire
1 year
SafetyStandard Complication Questionnaire
2 years
SafetyStandard Complication Questionnaire
3 years
SafetyStandard Complication Questionnaire
4 years
SafetyStandard Complication Questionnaire
5 years
SafetyPhysical Evaluation
6 months
Safety
Who could take part
Relapsing and progressive · 18 to 65
Show the full criteria
Inclusion criteria
* Confirmed Diagnosis of MS * Aged 18 - 65 years. * Duration of disease: >5 years * Signed, written informed consent willing and able to comply with study visits according to protocol for the full study period * Physically, mentally and legally capable of international travel for treatment
Exclusion criteria
* Patients suffering from significant cardiac, renal or hepatic failure or any other disease that may risk the patient or interfere with the ability to interpret the results * Patient with any active or chronic infection * No life-threatening organ dysfunction. * Pregnancy or risk of pregnancy. * Severe physical limitations or disabilities * Patients who are seropositive for HIV1, HIV2, Hepatitis B Surface Antigen, and Hepatitis C * Patients unable to give written informed consent in accordance with research ethics board guidelines * Treatment with any immunosuppressive therapy within the 3 months prior to randomization * Current treatment with an investigational therapy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The intent of this clinical study is to answer the questions: 1) is the proposed treatment safe and 2) is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes.
Papers
Loading reviews and guidelines…
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History
Started
Nov 2014
Main results due
May 2018
Finished
May 2018