Status:
NOT_YET_RECRUITING
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
Lead Sponsor:
Celltex Therapeutics Corporation
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=10...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04448106
Start Date
September 25 2023
End Date
August 15 2026
Last Update
April 18 2023
Active Locations (1)
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1
Stanley C Jones
Houston, Texas, United States, 77098