Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT04448106
Eligibility Criteria:
Inclusion Criteria:
* Age above 18 years
* Male or female
* Subjects in study group must have banked AdMSCs at Celltex (already passed communicable disease screen tests for HIV, syphilis and Hepatitis B and C during banking stage)
* Must understand and voluntarily sign an Informed Consent for study participation obtained prior to undergoing any study-specific procedures
* Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and physical examination.
Exclusion Criteria:
* Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
* Unwillingness or inability to comply with study procedures
* Patients with serious basic diseases that affect survival, including blood diseases, cachexia, active bleeding, severe malnutrition, etc.
* Clinically active malignant disease
* Previous thrombotic disorder
* History of known pulmonary embolism or known secondary anti-phospholipid syndrome
* Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g. BSA and sulfur-containing products (e.g., DMSO)
* Major trauma or surgery within 14 days of study treatment start
* Mental condition rendering the subject (or the subject's legally acceptable representative\[s\]) unable to understand the nature, scope and possible consequences of the study
* Alcohol, drug, or medication abuse within one year prior to study treatment start
* Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
* Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and renal failure due to other disease conditions
* Patients or family history with a hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
* History of long-term use of immunosuppressive agents
* Organ transplants in the previous 6 months
* Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04448106
Study Brief:
Protocol Section:
NCT04448106