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Not yet recruiting NCT04448106

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

Phase II Interventional Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Celltex- AdMSCs.
Who it may be relevant to
Registry conditions: Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis Shoulder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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).

Interventions

  • Biological Celltex- AdMSCs
    Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue

Primary outcome measures

  • the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects. [Time frame: 12 months]
  • Any organ damage or safety concerns determined by SMAC 20 blood test. [Time frame: 12 months]
Secondary outcome measures (7)
  • Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients [Time frame: 12 months]
  • Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients [Time frame: 12 months]
  • Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients [Time frame: 12 months]
  • Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients [Time frame: 12 months]
  • Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients [Time frame: 12 month]
  • Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients [Time frame: 12 months]
  • changes in joint images (X-ray or MRI) from the baseline [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanley C Jones — Houston

Identifiers

NCT: NCT04448106 · CTX0020-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗