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

Inclusion Criteria:

• 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

• Must have negative laboratory test results for human immunodeficiency virus,hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) at the ScreeningVisit

• 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 spermduring this period.

• A female is eligible to participate if she is not pregnant, not breastfeeding, andat 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 thetreatment period and for at least 3 months after the last dose of studytreatment.

• Female has a negative pregnancy test result at screening and prior toinvestigational medicinal product (IMP) administration

• Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in theprotocol

• Willing and able to comply with all study requirements, according to the judgment ofthe Investigator

• Has discontinued systemic oral or intravenous steroid use for 6 months prior toScreening

• Has vital sign measurements within the following ranges at Baseline (predose atVisit 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-inflammatorymedications, or injection therapy) within a 2-year period prior to the Screeningvisit.

• Study participant is able to speak, read, and understand English, in order tounderstand the nature of this study.

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 orcomparative 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 theopinion of the investigator, could jeopardize or would compromise the studyparticipant'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, ordiastolic blood pressure >90 mmHg), cardiovascular disease, asthma, or COPD.

• Is taking a prohibited medication or has taken a prohibited medication (narcoticpain 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 1month 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 startingstudy treatment or anticipation that such vaccine will be required during the studyPrior/concurrent clinical study experience

• Has current or chronic history of liver disease or known hepatic or biliaryabnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

• Has a positive urine drug screen (with the exception of benzodiazepine) prior todosing on Day 1. If a study participant presents with a positive drug screen, theparticipant 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 studymedication

• 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 pulsesteroid administration (eg, for flare up of nonarthritic condition or COVID-19).