Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness

PHASE2RecruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 19, 2024

Primary Completion Date

July 15, 2026

Study Completion Date

December 15, 2026

Conditions
Muscle PerformanceSarcopenic Obesity
Interventions
BIOLOGICAL

IMM01-STEM

IMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling. This intervention is given 2mL twice a week.

OTHER

Placebo

Saline. This intervention is given 2mL twice a week.

BIOLOGICAL

IMM01-STEM alternating with placebo (saline)

This intervention consists of IMM01-STEM given once a week and placebo given one a week. IMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling.

Trial Locations (4)

66219

RECRUITING

Johnson Country Clinical Trials (JCCT), Lenexa

67218

RECRUITING

Tekton Research, Wichita

91768

RECRUITING

National Institute of Clinical Research (NICR), Pomona

92844

RECRUITING

National Institute of Clinical Research (NICR), Garden Grove

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Immunis, Inc.

INDUSTRY