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

• ClinicalTrials.gov Identifier: NCT04448106
• Recruitment Status: Not yet recruiting
• First Posted: June 25, 2020
• Last Update Posted: July 8, 2021
• Sponsor: Celltex Therapeutics Corporation
• Information provided by (Responsible Party): Celltex Therapeutics Corporation

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Sally McGahee; 7135546847; smcgahee@celltexbank.com

Sponsors and Collaborators

Celltex Therapeutics Corporation

Investigators

• Principal Investigator: Derek W Guillory, MD.; Root Causes Medicine

More Information

• Responsible Party: Celltex Therapeutics Corporation
• ClinicalTrials.gov Identifier: NCT04448106
• Other Study ID Numbers: CTX0020-002
• First Posted: June 25, 2020
• Last Update Posted: July 8, 2021
• Last Verified: July 2021

• 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:

Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases