Autologous Stem/Stromal Cells in Neurological Disorders and Disease

Status unconfirmed · Not applicable

Conditions studied: Dementia, Parkinson, Altered Behavior in Alzheimer Disease, Demyelinating Autoimmune Diseases, CNS, Demyelinating Sensorimotor Neuropathy, Corticobasal Degeneration

In brief

The study deals with evaluation of safety and efficacy of use of stem/stromal cell isolates from autologous microvasculature in neurological, non-neoplastic disease. Autologous cells are acquired via microcannula aspiration of subdermal fat deposits, isolated through a digestive process, and concentrated via standard centrifugation. The cellular stromal vascular fraction (cSVF) created is neutralized and rinsed to eliminate residual enzymatic molecules. These cells are suspending in sterile Normal Saline Solution (500cc) and re-administered via an intravenous parenteral route, passed through a standard sterile 150 u (micron) filter in line. Multiple tracking and questionnaire followup is intended over a 5 year period, with objective and subjective criteria being met. Compilation and analysis of data to be completed after that period.

Key facts

Study ID

NCT03297177

Run by

Regeneris Medical

People needed

300

Starts

2020-01-01

Expected to finish

2023-01-01

Last updated by the study team

2018-10-18

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented Functional Neurological Damage To Central or Peripheral Nervous System Unlikely To Improve With Present Standard of Care Approaches
• At least 6 months after onset or diagnosis of disease process
• Current Medical therapy for the condition is either failing or not tolerated by patient
• Patient must be capable of interval neurologic exams with investigators or their own neurologic specialists
• Patient must be capable and determined competent to provide detailed informed consent for study participation
• In estimation of investigators, that there are minimal or no significant risk of harm to general health or conditions for collection of autologous stem cell collection and use

You may not qualify if…

• Inability of patient to have diagnostic examinations or studies (MRI) to evaluate and document the disease state or unwilling/unable to cooperate with such documentation
• Patients not medically stable, or whom may have ongoing conditions which increases may place the patient at significant risk of major complications, to be determined by investigator or patient's medical provider or neurologic specialists
• History of active cancer or ongoing anticancer therapy within six months of such care
• Women of childbearing age must not be pregnant at the time of treatment, and should refrain from becoming pregnant of at minimum of 3 month after study treatment

Where it is running

• Regeneris Medical Inc — North Attleboro, Massachusetts, United States
• Regeneris Medical — North Attleboro, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.