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

NCT04385056 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: IMAC-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Bradykinesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Serious Adverse Events and Adverse Events

  Number of serious adverse events and adverse events for the duration of the study.

  12 months

Study Arms (3)

Low Dose MSCTC-0010

EXPERIMENTAL

Participants will receive low-dose cell administration

Biological: MSCTC-0010

Medium Dose MSCTC-0010

EXPERIMENTAL

Participants will receive medium-dose cell administration

Biological: MSCTC-0010

High Dose MSCTC-0010

EXPERIMENTAL

Participants will receive high-dose cell administration

Biological: MSCTC-0010

Interventions

MSCTC-0010 BIOLOGICAL

MSCTC-0010 is a suspension product for infusion. The active ingredient is the umbilical cord-derived allogeneic mesenchymal stem cells (US-MSCs).

High Dose MSCTC-0010; Low Dose MSCTC-0010; Medium Dose MSCTC-0010

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• IMAC Holdings, Inc.: lead

Study Sites (3)

IMAC Regeneration Center

Paducah, Kentucky, 42001, United States

RECRUITING

Ozzie Smith IMAC Regeneration Center

Chesterfield, Missouri, 63017, United States

RECRUITING

David Price IMAC Regeneration Center

Brentwood, Tennessee, 37027, United States

RECRUITING

MeSH Terms

Conditions

Hypokinesia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christine Long

CONTACT

1 (844) 266-4622; contactus@imacregeneration.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 12, 2020
• Study Start: December 15, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)