55
Participants
Start Date
December 19, 2024
Primary Completion Date
July 15, 2026
Study Completion Date
December 15, 2026
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.
Placebo
Saline. This intervention is given 2mL twice a week.
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.
RECRUITING
Johnson Country Clinical Trials (JCCT), Lenexa
RECRUITING
Tekton Research, Wichita
RECRUITING
National Institute of Clinical Research (NICR), Pomona
RECRUITING
National Institute of Clinical Research (NICR), Garden Grove
Lead Sponsor
Immunis, Inc.
INDUSTRY