Evaluate Umbilical Cord-derived Allogeneic Mesenchymal Stem Cells for the Treatment of Bradykinesia

Status unconfirmed · Phase 1

Conditions studied: Bradykinesia

In brief

Investigate the safety and tolerability of umbilical cord-derived allogeneic mesenchymal stem cells to treat patients with Bradykinesia.

Key facts

Study ID

NCT04385056

Run by

IMAC Holdings, Inc.

People needed

15

Starts

2020-12-15

Expected to finish

2022-07-01

Last updated by the study team

2021-01-06

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age of 55 years or older
• Clinically diagnosed with Parkinsonism
• All subjects, or their authorized representatives, must be adequately informed and understand the nature and risks of the study and must be able to provide a signature and date in the Informed Consent Form (ICF).
• Clinically diagnosed bradykinesia for at least 3 months prior to baseline visit.
• On stable treatment regimen with L-dopa and other anti-parkinsonian treatment for 4 weeks prior to baseline.
• Women of child-bearing potential must undergo a negative serum pregnancy test at the screening assessment.
• Subjects, or their representatives, must be able to communicate effectively with the study staff.
• Subjects, or their authorized representatives, must certify that they are able and willing to follow all protocol requirements and study restrictions.

You may not qualify if…

• Subjects who are intolerant of, or unwilling to, participate in all procedures required of this protocol.
• Subjects who cannot tolerate a venipuncture and/or have adequate venous access.
• Inability to ambulate 100 feet independently with or without an assistive device.
• Subjects who have a history of allergy, hypersensitivity, or intolerance to any medications, components, or excipients of the investigational product or procedures, and which cannot be resolved by the staff conducting the study.
• Subjects with a known diagnosis of Atypical Parkinsonian Syndrome e.g.:
• Dementia with Lewy Bodies;
• Progressive Supranuclear Palsy;
• Corticobasal Degeneration;
• Multiple System Atrophy;
• Other Neurodengerative Conditions.
• Head trauma related to the onset of bradykinesia symptoms.
• History of repeated head injury, hydrocephalus, encephalitis, or cerebral tumors.
• Choreoathetosis
• Any documented abnormality in the brain by CT or MRI, which might contribute to the motor function, e.g., stroke, tumor, or other space-occupying lesions, hydrocephalus, or encephalomalacia.
• Known history of serum or plasma progranulin level < 110.9 ng/mL.
• Disease associated mutation in TDP-34, PGRN, CHMPB2, or VCP genes or any other FTLD Causative genes.
• Intracranial operation, e.g., pallidotomy, thalamotomy, and/or deep brain stiumulation surgery.
• Other known neurodegenerative diseases not underlying the bradykinesia, e.g., Spinocerellar Atropy (SCA), Wilson's Disease, or Amyotrphic Lateral Sclerosis (ALS).
• History of other significant neurological or physciatric disorders including, but not limited to, Alzheimer's disease, Lewy Body Dementia, Prior Disease, stroke, or seizure disorder.
• Psychiatric illness that is unrelated to the Bradykinesia, e.g., severe bipolar or unipolar depression.
• History of neurotoxin exposure.
• History of REM behavior disorder.
• Patients with Hepatocellular Carcinoma (HCC).
• Acute liver failure or episode of hepatic encephalopthy.
• Systolic blood pressure greater than 180 or less than 90 mmHg.

Where it is running

• IMAC Regeneration Center — Paducah, Kentucky, United States (enrolling)
• Ozzie Smith IMAC Regeneration Center — Chesterfield, Missouri, United States (enrolling)
• David Price IMAC Regeneration Center — Brentwood, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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