Status:
UNKNOWN
Autologous Stem/Stromal Cells in Neurological Disorders and Disease
Lead Sponsor:
Regeneris Medical
Collaborating Sponsors:
Global Alliance for Regenerative Medicine
Robert W. Alexander, MD, FICS
Conditions:
Dementia
Parkinson
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Dementia refers to neurodegenerative conditions causing gradual decrease in ability to think and recall, to the point that is impacts daily functions. It is often accompanied by language difficulties,...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03297177
Start Date
January 1 2020
End Date
January 1 2023
Last Update
October 18 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Regeneris Medical Inc
North Attleboro, Massachusetts, United States, 02760
2
Regeneris Medical
North Attleboro, Massachusetts, United States, 02760