Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCelltex Therapeutics Corporation
About this trial
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=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Celltex- AdMSCs
Treatment groups
300 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov