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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05211986
Recruitment Status : Not yet recruiting
First Posted : January 27, 2022
Last Update Posted : May 31, 2022
Sponsor:
Information provided by (Responsible Party):
Immunis, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Muscle Atrophy Drug: IMM01-STEM Phase 1 Phase 2

Detailed Description:

This will be an open-label, dose escalation study to assess the safety and tolerability of IMM01-STEM, a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules, in participants with muscle atrophy related to knee osteoarthritis (KOA).

Up to 18 participants will receive twice weekly intramuscular administration of IMM01-STEM for 4 weeks in up to 3 dose cohorts: Cohort A, IMM01-STEM 225μg; Cohort B, IMM01-STEM 450 μg; and Cohort C, IMM01-STEM 900 μg.

Study participants will sign a written Informed Consent Form (ICF) prior to the conduct of any study related procedures. A study participant who provides written informed consent will be screened within 28 days prior to treatment. Screening assessments will be conducted, after which the study participants' eligibility will be determined on the basis of the inclusion and exclusion criteria.

Eligible participants will be enrolled and undergo Baseline assessments on Day 1. Patients will receive IMM01-STEM twice a week for 4 weeks, for a total of 8 injections. Site staff will administer study medication by im injection using a small-gauge needle (eg, 24 or 26 Ga) at all scheduled visits. After each administration of study medication, participants will be observed for 3 hours to monitor for injection-related reactions and other early onset treatment-related adverse events (AEs), in particular for the presence of allergic reactions. After Visit 2 and 3, there will be follow-up phone contact 6 to 8 hours later the same day and once the day following each injection.

After their last injection, participants will enter a Safety Follow-Up (SFU) period, with clinic visits 3 days after their last injection and then monthly for 3 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 3 dose cohorts: Cohort A, IMM01-STEM 225μg; Cohort B, IMM01-STEM 450 μg; and Cohort C, IMM01-STEM 900 μg.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Dose Escalation Study to Assess the Safety and Tolerability of IMM01-STEM in Participants With Muscle Atrophy Related to Knee Osteoarthritis
Estimated Study Start Date : September 20, 2022
Estimated Primary Completion Date : January 28, 2023
Estimated Study Completion Date : April 22, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cohort A
Participants will receive twice weekly intramuscular (im) administration of IMM01 STEM for 4 weeks with a dose of 225μg.
Drug: IMM01-STEM
IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.

Active Comparator: Cohort B
Participants will receive twice weekly intramuscular (im) administration of IMM01 STEM for 4 weeks with a dose of 450μg.
Drug: IMM01-STEM
IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.

Active Comparator: Cohort C
Participants will receive twice weekly intramuscular (im) administration of IMM01 STEM for 4 weeks with a dose of 900μg.
Drug: IMM01-STEM
IMM01-STEM is a secretome product derived from partially differentiated pluripotent stem cells that contains regenerative molecules.




Primary Outcome Measures :
  1. Safety of IMM01-STEM treatment in study participants with muscle atrophy related to KOA [ Time Frame: Day 0 to Day 28 ]
    Determined by the incidence and severity of dose-limiting toxicities (DLTs) and the incidence of treatment-emergent adverse events (TEAEs). Adverse events (AE) are classified based on Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 0 = no adverse events, Grade 1= mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life threatening and Grade 5 = fatal adverse events. A DLT is defined as any AE related to IMM01-STEM of a Grade 2 unresolved within 48 hours post-injection, or any Grade 3, 4, or 5 related to IMM01-STEM during any time of treatment or during the 48-hour, acute/subacute observation period.


Secondary Outcome Measures :
  1. Safety and tolerability of IMM01-STEM after 4 weeks of treatment in study participants with muscle atrophy related to KOA [ Time Frame: Day 28 ]
    Determined by incidence, type and severity of adverse events graded according to CTCAE v5.0 and CRS revised grading system and defined by clinical relevant findings at day 28 post-treatment, or worsening of previous findings from baseline at day 28 post treatment in: self-reporting, physical examination, vital signs (body temperature, body weight, blood pressure, and heart rate), laboratory data (hematology, clinical chemistry, and urinalysis).

  2. Functionality of the knee joint after 4 weeks of treatment with IMM01-STEM in study participants with muscle atrophy related to KOA [ Time Frame: Day 28 ]
    Determined by evaluation of participants with changes from baseline at day 28 post treatment in: muscle strength (measured by isometric knee extensor torque), physical function (measured by the 6-minute walk test), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Has mild to moderate KOA (defined as Kellgren-Lawrence [KL] grade 2 to 3) on affected limb
  • Has quadriceps weakness (<7.5N/kg/m2)
  • Can ambulate >50 feet unassisted
  • Must have negative laboratory test results for human immunodeficiency virus, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) at the Screening Visit
  • Has a body mass index (BMI) of <40kg/m2
  • A male must agree to use contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
  • A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

    1. Not a woman of childbearing potential (WOCBP). OR
    2. A WOCBP who agrees to follow the protocol's contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
  • Female has a negative pregnancy test result at screening and prior to investigational medicinal product (IMP) administration
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
  • Willing and able to comply with all study requirements, according to the judgment of the Investigator
  • Has discontinued systemic oral or intravenous steroid use for 6 months prior to Screening
  • Has vital sign measurements within the following ranges at Baseline (predose at Visit 2): heart rate >50 and <100 bpm, systolic blood pressure >100 and <170 mmHg, diastolic blood pressure >50 and <90 mmHg, and blood oxygenation (by pulse-oximetry) >95%
  • Participant has undergone and failed at least 1 3-month or longer treatment regimen (ie, activity modification, weight loss, physical therapy, anti-inflammatory medications, or injection therapy) within a 2-year period prior to the Screening visit.

Exclusion Criteria:

  • Moderate to severe KOA (defined as KL grade >3) on contralateral limb
  • Has had prior total knee arthroplasty
  • Has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol
  • Has current or past history of malignancy (10y) excluding nonmelanoma skin cancer
  • Has neurological, vascular, or cardiac condition that limit function, or, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
  • Has uncontrolled comorbidities including diabetes, hypertension, cardiovascular disease, asthma, or COPD.
  • Is taking a prohibited medication or has taken a prohibited medication (narcotic pain medication, local anti-inflammatory, other investigational drugs)
  • Participant has had a change in medication to manage comorbid condition(s) (including diabestes, hypertension, asthma, and cardiovascular disease) within 1 month of the Screening visit.
  • Participant received intra-articular cortisone or viscosupplementation product(eg, Synvisc®) injections within 3 months prior to the first dose of IMP.
  • Has had administration of a live, attenuated vaccine within 28 days of starting study treatment or anticipation that such vaccine will be required during the study Prior/concurrent clinical study experience
  • Has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Has a positive urine drug screen (with the exception of benzodiazepine) prior to dosing on Day 1. If a study participant presents with a positive drug screen, the participant may be rescheduled at the discretion of an Investigator.
  • Has the presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb) test result at Screening or within 3 months prior to starting study medication
  • Tests positive for human immunodeficiency virus-1/2 antibody (human immunovirus 1/2Ab) at Screening or within 3 months prior to the first dose of study medication
  • Has current or past history (10y) of smoking
  • Has a history of chronic alcohol or drug abuse within the previous 3 months
  • Participant is currently using a systemic oral or intravenous steroid regimen (eg, for asthma or other chronic respiratory condition) or brief course of systemic pulse steroid administration (eg, for flare up of nonarthritic condition or COVID-19).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05211986


Contacts
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Contact: Joelle Hafen, BS 9496907911 Joelle@immunisbiomedical.com
Contact: Erin Curry, PA 9494783420 Erin@immunisbiomedical.com

Sponsors and Collaborators
Immunis, Inc.
Investigators
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Study Director: Tom Lane, PhD Chief Science Officer at Immunis, Inc.
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Responsible Party: Immunis, Inc.
ClinicalTrials.gov Identifier: NCT05211986    
Other Study ID Numbers: STEM-MYO
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Muscular Atrophy
Atrophy
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases