Safety Study of Intravenous MiraMSC in Older Adults With Mild to Moderate Frailty Syndrome

ConditionFrailty
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60-85
SponsorMiracle Biomedical Co., Ltd.

About this trial

The purpose of this Phase I, open-label study is to evaluate the safety and tolerability of intravenous MiraMSC-FS-001 in older adults with mild to moderate frailty syndrome. MiraMSC-FS-001 is an investigational product consisting of allogeneic umbilical cord-derived mesenchymal stem cells (UCMSCs). Eligible participants will receive intravenous administration of MiraMSC-FS-001.

Eligibility criteria

Qualifiers

Subjects aged ≥ 60 through ≤ 85 years old.

Subjects with clinical diagnosis of mild to moderate Frailty Syndrome as assessed by the Investigator with a Clinical Frailty Scale score between 4 to

The new treatment refers to any clinical study of new investigational therapies or any other stem cell therapies. Subject will be allowed to continue ongoing medications and therapies that are not prohibited treatment as listed in Section 6.4.1 and are deemed necessary by the Investigator for appropriate medical care. Minor modifications or dose adjustments to ongoing frailty- related treatments that were initiated prior to study enrollment and are not prohibited by the protocol may be implemented if deemed necessary by the Investigator for appropriate care; such adjustments will not be considered the initiation of a new treatment. ** 4. Subjects with body weight between 40 to 90 kg. 5. Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.

Disqualifiers

Subjects unwill ing or unable to perform any of the assessments required by endpoint analysis.

Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.

Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.

Severe kidney disease requiring hemodialysis or peritoneal dialysis;

Trial design

Treatments tested in this trial

  • MiraMSC-FS-001

Treatment groups

12 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators