Study to Assess the Safety and Effects of Autologous Adipose-Derived S
An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously Into Patients With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: company dissolved
What was tested
Treatment tested
- Harvesting and Implantation of SVF
What it measured
Main measures
Clinical improvement in disability score compared to baseline
3 months
Number of patients with adverse events
up to 6 months
SafetyClinical improvement in disability score compared to baseline
6 months
Other measures (4)
MS disease activity measured by the number of Gd-enhancing brain MRI lesions
3 months
MRI lesionsReduced number of relapses or freedom from progression of disease
3 months
RelapsesReduced number of relapses or freedom from progression of disease
6 months
RelapsesMS disease activity measured by the number of Gd-enhancing brain MRI lesions
6 months
MRI lesions
Who could take part
MS (type not specified) · 18 to 80
Show the full criteria
Inclusion criteria
* Males and Females between Age 18 and 80 years. * Duration of disease: >5 years * Failure to respond or intolerance to the currently available Multiple Sclerosis (MS) immunomodulatory treatments (ie interferons, Copaxone, immunosuppression): the lack of response to these treatments will be determined/defined by either an increase (deterioration) of at least one degree in the Expanded Disability Status Scale (EDSS) score during the last year or the appearance of at least two major relapses of MS during the same period of time (under treatment) or intolerance to these agents. * Up to date on all age and gender appropriate cancer screening per American Cancer Society .
Exclusion criteria
* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study * Life expectancy \< 6 months due to concomitant illnesses. * Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. * Active infectious disease. For patients who have tested positive, an expert will be consulted as to patient eligibility based on the patient's infectious status * Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results * Patients on chronic immunosuppressive transplant therapy * Systolic blood pressure (supine) ≤90 mmHg; * Resting heart rate > 100 bpm; * Active clinical infection. * Cerebrovascular accident within 6 months prior to study entry * Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. * History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * Unwilling and/or not able to give written informed consent.
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 2. Is treatment effective in improving the disease pathology of patients with Multiple Sclerosis and clinical outcomes?
Papers
Loading reviews and guidelines…
History
Started
Apr 2016
Main results due
Dec 2018
Finished
Apr 2019