Autologous Stem/Stromal Cells in Neurological Disorders and Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03297177
• Date of registration: 26/09/2017
• Prospective Registration: Yes
• Primary sponsor: Regeneris Medical
• Public title: Autologous Stem/Stromal Cells in Neurological Disorders and Disease NDD
• Scientific title: Use Of Autologous Stem Cell Use In Neurological Non-neoplastic Disorders And Disease
• Date of first enrolment: January 1, 2020
• Target sample size: 300
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03297177
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Honduras, United States

Contacts

• Name: Robert W Alexander, MD
• Affiliation: Healeon Medical

• Name: Glenn C Terry
• Affiliation: Global Alliance for Regenerative Medicine (GARM)

• Name: Ryan Welter, MD, PhD

• Name: Ryan Welter, MD, PhD
• Affiliation: Regeneris Medical Inc

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dementia

Altered Behavior in Alzheimer Disease

Demyelinating Autoimmune Diseases, CNS

Parkinson

Corticobasal Degeneration

Demyelinating Sensorimotor Neuropathy

Intervention(s)

Procedure: Sterile Normal Saline Infusion

Procedure: Microcannula Harvest Adipose

Device: Centricyte 1000

Primary Outcome(s)

Number of participant with adverse events (AE) or severe adverse events (SAE) [Time Frame: 6 month intervals for up to 5 years]

Secondary Outcome(s)

Magnetic Resonance Imaging (MRI) [Time Frame: 6 month intervals for up to 5 years]

Neurological Function [Time Frame: 6 month Intervals for up to 5 years]

Neurological Tested Functions [Time Frame: 6 month interval for up to 5 years]

Secondary ID(s)

GARM NDD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneris Medical Inc

Global Alliance for Regenerative Medicine

Robert W. Alexander, MD, FICS