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Safety and Tolerability of IMM01-STEM in Patients With Muscle Atrophy Related to Knee Osteoarthritis.

NCT05211986 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-10-30

No results posted yet for this study

Summary

An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participants with muscle atrophy related to knee osteoarthritis

Conditions

  • Muscle Atrophy

Interventions

DRUG

IMM01-STEM

IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.

Sponsors & Collaborators

  • Immunis, Inc.

    lead INDUSTRY

Principal Investigators

  • Tom Lane, PhD · Chief Science Officer at Immunis, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-13
Primary Completion
2026-03-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211986 on ClinicalTrials.gov