RecruitingPhase 1Phase 2NCT05211986

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

An Open-label Dose Escalation Study to Assess the Safety and Tolerability of IMM01-STEM in Participants With Muscle Atrophy Related to Knee Osteoarthritis

Sponsor

Immunis, Inc.

Enrollment

28 participants

Start Date

Sep 13, 2022

Study Type

INTERVENTIONAL

Conditions

Muscle Atrophy

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

Eligibility

Min Age: 50 YearsMax Age: 75 Years

Inclusion Criteria16

Has moderate KOA (defined as Kellgren-Lawrence \[KL\] grade 2 to 3) on affected limb
Has quadriceps weakness (\<7.5N/kg)
Can ambulate \>50 feet unassisted
This criteria deleted with protocol amendment 6
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:
Not a woman of childbearing potential (WOCBP). OR
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.
Study participant is able to speak, read, and understand English, in order to understand the nature of this study.

Exclusion Criteria18

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 (5y) 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 (hemoglobin A1c level \>7.0%), Hypertension (resting heart rate \>100 bpm, systolic blood pressure \>170 mmHg, or diastolic blood pressure \>90 mmHg), cardiovascular disease, asthma, or COPD.
Is known positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) or human immunodeficiency virus-1/2 antibody (HIV-1/2Ab). Patients with a negative RNA test for HCV are acceptable.
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)
This criteria was deleted with protocol amendment 6
This criteria was deleted with protocol amendment 6
This criteria was deleted with protocol amendment 6
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).

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Interventions

DRUGIMM01-STEM

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

Locations(2)

Orthopaedic Specialty Institute

Irvine, California, United States

University of California, Irvine - Alpha Stem Cell Clinic

Orange, California, United States

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NCT05211986

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