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

Osteoarthritis, Knee Clinical Trial

— AdMSCs  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04448106
• Other study ID #: CTX0020-002
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 25, 2023
• Est. completion date: August 15, 2026

Study information

• Verified date: April 2023
• Source: Celltex Therapeutics Corporation
• Contact: Jane Young
• Phone: 7135901000
• Email: jyoung[@]celltexbank.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: August 15, 2026
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Shoulder
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Stanley C Jones	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Celltex Therapeutics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline	efficacy	12 months
Other	Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline	efficacy	12 months
Primary	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.	safety	12 months
Primary	Any organ damage or safety concerns determined by SMAC 20 blood test.	Safety	12 months
Secondary	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	efficacy	12 months
Secondary	Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients	efficacy	12 months
Secondary	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	efficacy	12 months
Secondary	Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients	efficacy	12 months
Secondary	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	efficacy	12 month
Secondary	Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients	efficacy	12 months
Secondary	changes in joint images (X-ray or MRI) from the baseline	efficacy	12 months