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Stem Cell Therapy
IMM01-STEM for Muscle Wasting in Knee Osteoarthritis
Phase 1 & 2
Recruiting
Research Sponsored by Immunis, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has moderate KOA (defined as Kellgren-Lawrence [KL] grade 2 to 3) on affected limb
Has quadriceps weakness (<7.5N/kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights
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.
Who is the study for?
This trial is for adults with moderate knee osteoarthritis and muscle weakness who can walk unassisted, have a BMI under 40, are not pregnant or breastfeeding, agree to use contraception, and do not have certain health conditions like severe liver disease or recent drug abuse. Participants must also be non-smokers for at least 10 years.Check my eligibility
What is being tested?
The study tests the safety of IMM01-STEM in patients with muscle wasting due to knee osteoarthritis. It's an open-label trial where everyone gets the treatment; doses increase over time to find out what's safe.See study design
What are the potential side effects?
While specific side effects aren't listed here, this type of study typically looks for any adverse reactions ranging from mild (like injection site pain) to serious (like allergic reactions). Patients will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee arthritis is moderate, between grades 2 to 3.
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My thigh muscles are weak.
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I can walk more than 50 feet by myself.
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I am not pregnant, as confirmed by a test.
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I haven't taken any oral or IV steroids for the last 6 months.
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I have tried a treatment for 3 months or more that didn't work within the last 2 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of IMMUNA(IMM01-STEM) treatment in study participants with muscle atrophy related to KOA
Secondary outcome measures
Functionality of the knee joint after 4 weeks of treatment with IMMUNA(IMM01-STEM) in study participants with muscle atrophy related to KOA
Safety and tolerability of IMMUNA(IMM01-STEM) after 4 weeks of treatment in study participants with muscle atrophy related to KOA
Trial Design
3Treatment groups
Active Control
Group I: Cohort BActive Control1 Intervention
Participants will receive twice weekly intramuscular (im) administration of IMMUNA(IMM01-STEM) for 4 weeks with a dose of 450μg.
Group II: Cohort AActive Control1 Intervention
Participants will receive twice weekly intramuscular (im) administration of IMMUNA(IMM01-STEM) for 4 weeks with a dose of 225μg.
Group III: Cohort CActive Control1 Intervention
Participants will receive twice weekly intramuscular (im) administration of IMMUNA(IMM01-STEM) for 4 weeks with a dose of 900μg.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Immunis, Inc.Lead Sponsor
Tom Lane, PhDStudy DirectorChief Science Officer at Immunis, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for hepatitis B or hepatitis C within the last 3 months.You have had a problem with drinking alcohol or using drugs regularly in the past 3 months.My thigh muscles are weak.I am not pregnant or breastfeeding and either cannot become pregnant or will follow the study's birth control advice.Your vital signs, like your temperature, blood pressure, and heart rate, are within certain normal ranges before starting the study.I am not pregnant, as confirmed by a test.I haven't taken any oral or IV steroids for the last 6 months.I have tried a treatment for 3 months or more that didn't work within the last 2 years.I changed my medication for another health condition within the last month.I am not currently taking, nor have I recently taken, any prohibited medications.You have tested positive for HIV within the last 3 months.I agree to use birth control and not donate sperm for 3 months after my last treatment dose.I have had joint injections within the last 3 months.I have smoked in the past 10 years or am currently smoking.I have not received a live vaccine in the last 28 days and do not plan to during the study.I have had a total knee replacement surgery.My other knee has moderate to severe arthritis.I have had cancer other than non-melanoma skin cancer in the past 10 years.I have a history of liver disease or liver abnormalities.I tested positive for drugs (except for benzodiazepines) before starting the treatment.I do not have heart, blood vessel, or nerve conditions that could affect my participation.I have uncontrolled health issues like diabetes or high blood pressure.I am currently taking steroids through pills or IV.My knee arthritis is moderate, between grades 2 to 3.I can walk more than 50 feet by myself.You must have test results showing that you do not have HIV, hepatitis B, or hepatitis C.You have a body mass index (BMI) below 40.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort A
- Group 3: Cohort C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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"
Answered by AI
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."
Answered by AI
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."
Answered by AI
Are participants in this trial limited to those under sixty years of age?
"This study welcomes those aged between 50 and 75."
Answered by AI
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