Cohort A for Muscle Wasting

University of Utah, Salt Lake City, UT
Muscle WastingIMM01-STEM - Drug
Eligibility
50 - 75
All Sexes

Study Summary

This trial will test a new drug, IMM01-STEM, to see if it is safe and tolerated in people with knee osteoarthritis-related muscle atrophy.

Eligible Conditions
  • Muscle Wasting

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 28

Day 28
Safety of IMM01-STEM treatment in study participants with muscle atrophy related to KOA
Day 28
Functionality of the knee joint after 4 weeks of treatment with IMM01-STEM in study participants with muscle atrophy related to KOA
Safety and tolerability of IMM01-STEM after 4 weeks of treatment in study participants with muscle atrophy related to KOA

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

Cohort A
1 of 3
Cohort B
1 of 3
Cohort C
1 of 3

Active Control

18 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort A · No Placebo Group · Phase 1 & 2

Cohort A
Drug
ActiveComparator Group · 1 Intervention: IMM01-STEM · Intervention Types: Drug
Cohort B
Drug
ActiveComparator Group · 1 Intervention: IMM01-STEM · Intervention Types: Drug
Cohort C
Drug
ActiveComparator Group · 1 Intervention: IMM01-STEM · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 28

Who is running the clinical trial?

Immunis, Inc.Lead Sponsor
Tom Lane, PhDStudy DirectorChief Science Officer at Immunis, Inc.

Eligibility Criteria

Age 50 - 75 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

To whom does the criteria for this research apply?

"This clinical trial seeks 18 individuals aged between 50 and 75 who suffer from arthrosis. Prerequisites include being able to independently walk more than 50 feet, having a BMI below 40kg/m2, no pre-existing HIV or HBsAg or HCV infections, males agreeing to use contraception for 3 months post treatment, WOCBP must adhere with the protocol's contraceptive instructions during treatment and after last dose of study medication; female participants need negative pregnancy test at screening before receiving IMP; signing informed consent form that includes compliance with all requirements in it; 6 months steroid abstinence prior to Screening Visit; Kellgren-Lawrence grade" - Anonymous Online Contributor

Unverified Answer

Is the enrollment period for this clinical trial still open?

"The information posted on clinicaltrials.gov indicates that this medical research is recruiting participants at present. The trial was initially published on September 13th 2022 and the most recent update occurred four days later, on September 16th." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of individuals involved in this investigation?

"Affirmative. The trial details, initially posted on September 13th 2022 and recently updated on the 16th of that same month, are available to view online via clinicaltrials.gov--and state that 18 participants are currently needed between two separate sites." - Anonymous Online Contributor

Unverified Answer

Are participants in this trial limited to those under sixty years of age?

"This study welcomes those aged between 50 and 75." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.