Rheumatoid ArthritisPhase 1/2NCT04170426
Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis
A Phase 1/2 study testing autologous adipose derived stem cells in people with Rheumatoid Arthritis, run by Celltex Therapeutics Corporation.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- autologous adipose derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Unwillingness or inability to comply with study procedures
- 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.
- 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
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- autologous adipose derived stem cells
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous adipose derived stem cellsBiological
Also called Celltex-AdMSCs
Culture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 ARM 0 | Experimental | 9 subjects receive dose escalation of autologous AdMSCs via Intravenous infusion in Phase 1 Receives: Biological: autologous adipose derived stem cells |
| Phase 2 ARM 1 | Active comparator | 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 Receives: Biological: autologous adipose derived stem cells |
| Phase 2 ARM 2 | Placebo comparator | 15 subjects receive three doses of placebo on day 1, 4 and 7 via Intravenous infusion in Phase 2a Receives: Biological: autologous adipose derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events and Sever Adverse Events
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.
Measured: 52 weeks
Secondary outcomes (1)
Efficacy of Celltex AdMSCs
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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study using autologous adipose stem cells (Celltex AdMSCs) for rheumatoid arthritis patients who failed disease-modifying antirheumatic drug (DMARDs).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltex Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Derek W Guillory, MD, Principal investigator, Root Causes Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170426
- Sponsor's protocol ID
- CTX0019-001
- Status last verified
- Apr 2023
- First submitted
- 18 Nov 2019
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04170426
- Acronym / sponsor ID
- CTX0019-001
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Celltex Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Combined Phase 1 dose escalation study and Phase 2a randomized, placebo controlled and double blinded study using autologous adipose stem cells (Celltex AdMSCs) for rheumatoid arthritis patients who failed disease-modifying antirheumatic drug (DMARDs).
| Arm | Type | Receives |
|---|---|---|
| Phase 1 ARM 0 | Experimental | Biological: autologous adipose derived stem cells9 subjects receive dose escalation of autologous AdMSCs via Intravenous infusion in Phase 1 |
| Phase 2 ARM 1 | Active comparator | Biological: autologous adipose derived stem cells30 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 |
| Phase 2 ARM 2 | Placebo comparator | Biological: autologous adipose derived stem cells15 subjects receive three doses of placebo on day 1, 4 and 7 via Intravenous infusion in Phase 2a |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (27 listed)
- Current or prior to treatment
- Concurrent Conditions
- Laboratory Parameters
- Pregnancy / contraception
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous adipose derived stem cellsAlso: Celltex-AdMSCsCulture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue | Biological | Phase 1 ARM 0, Phase 2 ARM 1, Phase 2 ARM 2 |
Primary outcome
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.
1 secondary outcome
Efficacy of Celltex AdMSCs
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Derek W Guillory, MD principal investigator
Root Causes Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing autologous adipose derived stem cells in people with Rheumatoid Arthritis, run by Celltex Therapeutics Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Young (7135901000, jyoung@celltexbank.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events and Sever Adverse Events (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.