Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis

April 13, 2023 updated by: Celltex Therapeutics Corporation

Phase 1/2a Clinical Study for Subjects With Rheumatoid Arthritis (RA) Using Multiple Dose Intravenous Infusions of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)

This is an investigational new drug clinical trial for combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study using intravenous injection of autologous adipose stem cells (Celltex AdMSCs) for rheumatoid arthritis patients. All subjects are monitored for safety (adverse events/severe adverse events) and evaluated for RAPID3, DAS28 and ACR20 regarding AdMSCs up to 52 weeks study duration.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must pass communicable disease screen tests for HIV, syphilis, Hepatitis B and C Consistent with American Rheumatism Association-European League Against Rheumatism (ACR/EULAR) 2010 rheumatoid arthritis classification criteria
  • Active Rheumatoid Arthritis, see RA functional status of class I-IV
  • Patients must meet at least one of the following: > 6 swollen joints and ≥ 6 involved joints (tenderness, swelling, deformity, pain on motion, or decreased motion) and morning stiffness ≥ 45 minutes based on 68 joint count.
  • Patients must also meet at least one of the following: rheumatoid factor (RF) > 15 IU/mL or > 1:16, C-reactive protein (CRP) > 2.0 mg/dL, Erythrocyte Sedimentation Rate (ESR) > 30 mm/hour, and anti-cyclic citrullinated protein (Anti-CCP) > 20 U/mL, TNFα > 2.8 pg/mL.
  • Patients must have failed anti-rheumatoid drug due to adverse event or inefficacy for at least 12 week and at least 4 weeks on stable dose of methotrexate ≤ 25 mg/week, or leflunomide ≤ 20 mg/day, or sulfasalazine ≤ 3 g/day, or steroids (Prednisone <10 mg/day).
  • For other medications, patients must be on the stable dose for at least 4 weeks prior to study entry in order to preclude changes to patient medication while participating on the study to ensure that a medication change could become a confounding factor in data interpretation.
  • All patients must be clinically stable with no significant changes in health status a minimum of at least 4 weeks prior to randomization and confirming patient eligibility

Exclusion Criteria:

  1. Current or prior to treatment

    • Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
    • Evidence of immune suppression related to prior/current therapy
    • > 10% change in delivered monthly dose of anti-rheumatoid medications within 4 weeks prior to this stem cell infusion
    • Use of a new or additional anti-rheumatoid medication within 6 weeks prior to this stem cell infusion
    • Use of other stem cell therapy within 12 weeks prior to this stem cell therapy
    • Unwillingness or inability to comply with study procedures

  2. Concurrent Conditions

    • Clinically active malignant disease
    • Severe bladder or thrombotic disorder
    • History of known pulmonary embolism or known secondary anti-phospholipid syndrome
    • Known or suspected hypersensitivity to any components used to culture or store the AdMSCs, e.g. sulfur or sulfonamide
    • Known or suspected antibodies to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)
    • Active infection at time of planned study treatment start
    • Age related pathology likely to inhibit study participation or completion
    • 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 before 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
    • Heavy smokers, bed-bound patients, patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.

  3. Laboratory Parameters

    • Hepatic impairment, defined as any of ALT, AST, LDH or bilirubin > 2 x the upper limit of normal (ULN) range according to local laboratory standards
    • Renal impairment, defined as serum creatinine > 133 mmol/L (1.5 mg/dL)
    • Positive virology/serology for human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), hepatitis C and/or syphilis

  4. Pregnancy / contraception

    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1 ARM 0
9 subjects receive dose escalation of autologous AdMSCs via Intravenous infusion in Phase 1
Biological: autologous adipose derived stem cells
Culture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue
Other Names:
  • Celltex-AdMSCs
Active Comparator: Phase 2 ARM 1
30 subjects receive three doses of 2.0-2.86×10^6 cells/kg on day 1, 4 and 7 via Intravenous infusion in Phase 2a
Biological: autologous adipose derived stem cells
Culture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue
Other Names:
  • Celltex-AdMSCs
Placebo Comparator: Phase 2 ARM 2
15 subjects receive three doses of placebo on day 1, 4 and 7 via Intravenous infusion in Phase 2a
Biological: autologous adipose derived stem cells
Culture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue
Other Names:
  • Celltex-AdMSCs

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events and Sever Adverse Events
Time Frame: 52 weeks
The total number of adverse events and severe adverse events related and non-related with AdMSCs will be recorded to indicate the safety and tolerability.
52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy of Celltex AdMSCs
Time Frame: 52 weeks
Proportion of ACR 20 patients (swollen joints, tender joints, patient assessment of pain, RAPID3, DAS28-CRP and blood inflammatory panel tests) in comparison between baseline and post-treatment follow-up data.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celltex Therapeutics Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Derek W Guillory, MD, Root Causes Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTX0019-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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