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NCT Number: NCT04448106

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celltex- AdMSCs

Biological

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

Other names: AdMSCs

Primary outcomes

  1. 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

    safety

  2. Any organ damage or safety concerns determined by SMAC 20 blood test.

    Time frame: 12 months

    Safety

Secondary outcomes

  1. 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

    efficacy

  2. 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

    efficacy

  3. 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

    efficacy

  4. 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

    efficacy

  5. 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

    efficacy

  6. 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

    efficacy

  7. changes in joint images (X-ray or MRI) from the baseline

    Time frame: 12 months

    efficacy

Other outcomes

  1. Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline

    Time frame: 12 months

    efficacy

  2. Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline

    Time frame: 12 months

    efficacy

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Young

CONTACT

[email protected]

7135901000

Sponsors and collaborators

Lead sponsor

Celltex Therapeutics Corporation

Industry

Registry information

Official study 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)

Acronym: AdMSCs

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 25, 2020
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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