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

UCI Specialty Area: Orthopaedics

Principal Investigator: Dean Wang

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

A Study On:

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.

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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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
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You are being asked to participate in a clinical research potential participant database to identify
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time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

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