An open-label dose escalation study to assess the safety and tolerability of IMM01-STEM in participa

Orthopaedics
Dean Wang
AN OPEN-LABEL DOSE ESCALATION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF IMM01-STEM IN PARTICIPANTS WITH MUSCLE ATROPHY RELATED TO KNEE OSTEOARTHRITIS
Osteoarthritis

Study 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 KOA.

Eligibility

Inclusion criteria:

  • Study participant must be 50 to 75 years of age, inclusive, at the time of signing the informed consent.
  • Study participant has moderate KOA (defined as Kellgren-Lawrence [KL] grade 2 to 3) on affected limb.
  • Study participants has quadriceps weakness (<7.5N/kg/m2) for the measurement methodology).
  • Study participant can ambulate >50 feet unassisted.
  • Study participant must have negative laboratory test results for human immunodeficiency virus, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) at the Screening Visit.
  • Study participant has a body mass index (BMI) of <40kg/m2
  • The study participant is male or female.
  • A male participant must agree to use contraception as detailed in of this protocol 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 participant 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) as defined.

OR

  • A WOCBP who agrees to follow the contraceptive guidance in during the treatment period and for at least 3 months

after the last dose of study treatment.

  • Female participant has a negative pregnancy test result at Screening and prior to investigational medicinal product

(IMP) administration.

  • Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Study participant is able to speak, read, and understand English, in order to understand the nature of this study.
  • Study participant is willing and able to comply with all study requirements, according to the judgment of the Investigator.
  • Participant has discontinued systemic oral or intravenous steroid use for 6 months prior to Screening.
  • Participant 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:

  • Study participant has moderate to severe KOA (defined as KL grade >3) on contralateral limb.
  • Study participant has had prior total knee arthroplasty.
  • Study participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol.
  • Study participant has current or past history of malignancy (10y) excluding nonmelanoma skin cancer.
  • Study participant 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.
  • Study participant has uncontrolled comorbidities including diabetes (hemoglobin A1c level >7.0%), Hypertension (resting heart rate >100 bpm, systolic blood pressure >170 mmHg, or diastolic blood pre
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