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

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ClinicalTrials.gov Identifier: NCT04448106
Recruitment Status : Not yet recruiting
First Posted : June 25, 2020
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
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 Intervention/treatment Phase
Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis Shoulder Biological: Celltex- AdMSCs Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.
Masking: Double (Participant, Outcomes Assessor)
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)
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Phase 2 Arm 1 - OA Knee

50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.

On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.

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

Active Comparator: Phase 2 Arm 2 OA Knee
Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
Biological: Celltex- AdMSCs
Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Other Name: AdMSCs

Experimental: Phase 2 Arm 3 - OA Hip

50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.

On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.

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

Active Comparator: Phase 2 Arm 4 - OA Hip
Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
Biological: Celltex- AdMSCs
Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Other Name: AdMSCs

Experimental: Phase 2 Arm 5 - OA Shoulder

50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.

On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.

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

Active Comparator: Phase 2 Arm 6 - OA Shoulder
Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
Biological: Celltex- AdMSCs
Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
Other Name: AdMSCs




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448106


Contacts
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Contact: Sally McGahee 7135546847 smcgahee@celltexbank.com

Sponsors and Collaborators
Celltex Therapeutics Corporation
Investigators
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Principal Investigator: Derek W Guillory, MD. Root Causes Medicine
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Responsible Party: Celltex Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT04448106    
Other Study ID Numbers: CTX0020-002
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celltex Therapeutics Corporation:
Autologous Adipose-derived Stem Cells (AdMSCs)
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases