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

This study is investigating a treatment called Celltex-AdMSCs for osteoarthritis in the knees, hips, and shoulders. Celltex-AdMSCs are mesenchymal stem cells taken from your own abdominal fat tissue. The study aims to see how safe this treatment is by tracking any side effects over 12 months and checking for organ damage with a blood test. You can join if you are over 18 years old and have osteoarthritis. You must also have previously banked your AdMSCs at Celltex and passed certain health screenings. The study plans to enroll 300 participants, but its current status is unclear.

Study design: This is a Phase 2, open-label study with 6 groups, including a study group and a control group for each joint type. It will involve 300 participants with osteoarthritis of the knees, hips, or shoulders.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 12 months to monitor for adverse events and safety concerns.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

UNKNOWN

PHASE2Ages 18+InterventionalTreatment

Celltex Therapeutics Corporation

~300 participants

Updated 2023-04-18 on ClinicalTrials.gov

What's tested:Celltex- AdMSCs

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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.

Measured over 12 months

+1 more outcome measured

Conditions

Osteoarthritis, Knee

Osteoarthritis, Hip

Osteoarthritis Shoulder

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Derek W Guillory, MD. · PRINCIPAL_INVESTIGATOR · Root Causes Medicine

Who to contact

Jane Young

[email protected]

7135901000

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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.12 months
safety
Any organ damage or safety concerns determined by SMAC 20 blood test.12 months
Safety

Trialytics