Clinical trial NCT04448106: Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Osteoarthritis Shoulder
Keywords: Autologous Adipose-derived Stem Cells (AdMSCs)
Lead sponsor: Celltex Therapeutics Corporation
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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.
timeFrame: 12 months
measure: Any organ damage or safety concerns determined by SMAC 20 blood test.
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
timeFrame: 12 months
measure: 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
timeFrame: 12 month
measure: Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
timeFrame: 12 months
measure: changes in joint images (X-ray or MRI) from the baseline
timeFrame: 12 months
Other outcomes:
measure: Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline
timeFrame: 12 months
measure: Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline
timeFrame: 12 months
Locations:
city: Houston
country: United States
facility: Stanley C Jones
state: Texas
Study officials:
affiliation: Root Causes Medicine
name: Derek W Guillory, MD.
role: PRINCIPAL_INVESTIGATOR
References: