Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis

Launched by CELLTEX THERAPEUTICS CORPORATION · Jun 23, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for osteoarthritis, a common condition that causes pain and stiffness in the knees, hips, and shoulders. Researchers are studying the use of a specific type of stem cell, called autologous adipose tissue-derived mesenchymal stem cells (AdMSCs), which are derived from the patient's own body fat. The goal is to see if these stem cells can help improve symptoms like pain and mobility in people suffering from osteoarthritis. The study will involve 300 participants, divided into groups based on which joint is affected, and will evaluate their progress using established measurement tools.

To be eligible for this study, participants must be at least 18 years old and have a confirmed diagnosis of osteoarthritis in their knees, hips, or shoulders. They also need to have already stored their adipose-derived stem cells at a facility called Celltex. Participants will be closely monitored throughout the trial, including assessments of their symptoms and daily activities. It’s important to note that certain health conditions or recent medical events may disqualify individuals from participating. Overall, this trial aims to find new ways to help people manage their osteoarthritis symptoms and improve their quality of life.

Gender

ALL

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