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NCT04448106 | NOT YET RECRUITING | Osteoarthritis, Knee

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

Celltex Therapeutics Corporation

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=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).

Condition or disease

Osteoarthritis, Knee

Osteoarthritis, Hip

Osteoarthritis Shoulder

Intervention/treatment

Celltex- AdMSCs

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : DOUBLE
Masking Description : Patients and evaluators
Primary Purpose : TREATMENT
Official Title : Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)
Actual Study Start Date : 2023-09-25
Estimated Primary Completion Date : 2024-08-01
Estimated Study Completion Date : 2026-08-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis

Location Details

NCT04448106

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Texas

Stanley C Jones

Houston, Texas, United States, 77098