Rheumatoid ArthritisPhase 1/2HB-adMSCsNCT03691909
Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis
A Phase 1/2 study testing HB-adMSCs in people with Rheumatoid Arthritis, run by Hope Biosciences LLC at 1 site in United States.
Trial summary
Hope Biosciences is conducting a research study of an investigational product called Hope Biosciences autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for Rheumatoid Arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- HB-adMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2018to 28 Sep 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female between the ages of 18 and 65
- Patients have active RA as confirmed by the following criteria:
- ≥ 6 swollen joints and ≥ 6 tender joints at screening (68-joint count)
- Abnormal CRP result OR abnormal ESR result at screening. Abnormal CRP result at screening OR abnormal ESR defined as:
- CRP > 4.9 mg/L or ESR > 10mm/hr for men, > 20mm/hr for women
- Patients without current established treatment, or if being treated, patients who are on a stable dose of RA therapy regimen for ≥ 4 weeks prior to screening
Who cannot join
- Inability to understand and provide signed informed consent
- Pregnancy, lactation, or, if female of childbearing potential, positive serum β-hCG at screening.
- Currently diagnosed any malignant neoplasm. Any patient who was successfully treated for cancer and has been disease-free, with no recurrence, for at least 5 years, will be considered.
- Uncontrolled systemic illness, including, but not limited to: hypertension (systolic >150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or cardiac failure or any laboratory abnormality that poses a safety risk to the subject such as:
- Hemoglobin ≤8.5 g/dL
- White blood cells (WBCs) ≤3,500/mm3 (3.5 G/L)
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- Any other illness which, in the opinion of the investigator, characterizes the subject as not being a good candidate for the study
- Participation in another study with an investigational drug or device within 4 weeks prior to treatment or 5 half-lives of the investigational product used (whichever is longer).
- Positive results of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), and/or human immunodeficiency virus antibody (HIV Ab) tests at screening (excluding patients who are tested positive for HBsAb alone due to a hepatitis B vaccination).
- Positive history of Treponema pallidum.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis
Hope Biosciences is conducting a research study of an investigational product called Hope Biosciences autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for Rheumatoid Arthritis (RA). The study purpose is to evaluate the safety profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.
Read the detailed description
This is a Phase 1/2a, open-label, single-dose study in subjects with active Rheumatoid Arthritis (RA). 12-15 patients will be enrolled for the study. The overall objective of this study is to evaluate the safety profile of a single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA. The primary endpoint of this study is to measure the number and frequency of adverse event(s) and/or severe adverse event(s) throughout the study duration. The second endpoint of this study is to evaluate the ability of HB-adMSCs to alter RA-related inflammation via measuring levels of Tumor Necrosis Factor alpha (TNF-a), Interleukin-6 (IL-6), C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR) and Joint Count 66/68 after a single infusion of autologous HB-adMSCs for up to 12-month post-infusion.
- Conditions
- Rheumatoid Arthritis
- Being tested
- HB-adMSCs
- Keywords
- arthritis, stem cells, MSCs, adipose MSCs
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB-adMSCsBiological
Hope Biosciences autologous adipose-derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Single IV administration of autologous adipose-derived mesenchymal stem cells Baseline laboratory data will be collected prior to infusion; follow up data will be compared against baseline at 1, 3, 6 and 12 months. Joint Assessment 68 will be administered at 1, 3, 6 and 12 months. Receives: Biological: HB-adMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Adverse Events and Serious Adverse Events
Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.
Measured: 12 months
Secondary outcomes (5)
The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA
Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of Tumor Necrosis factor (TNF-a) (pg/mL) measured during trial.
Measured: 12 months
The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA
Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of interleukin 6 (IL-6) (pg/mL) during the trial
Measured: 12 months
The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA
Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of C-reactive protein (CRP) (mg/L) during the trial
Measured: 12 months
The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA
Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of erythrosedimentation rate (ESR) (mm/hr) during the trial.
Measured: 12 months
The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.
Efficacy is a secondary endpoint for this study and will be assessed by comparing the levels of Joint Count 66/68 (# joints - tender and swollen) during the trial.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start25 Sep 2018
- Primary completion17 Aug 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hope Biosciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Waller, MD, Principal investigator, Accurate Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691909
- Sponsor's protocol ID
- HBRA01
- Acronym
- HB-adMSCs
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2018
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vij R, Stebbings KA, Kim H, Park H, Chang D. Safety and efficacy of autologous, adipose-derived mesenchymal stem cells in patients with rheumatoid arthritis: a phase I/IIa, open-label, non-randomized pilot trial. Stem Cell Res Ther. 2022 Mar 3;13(1):88. doi: 10.1186/s13287-022-02763-w.
PubMed 35241141
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Clinical Trial to Assess Safety of a Single IV Infusion of Autologous Adipose-derived Mesenchymal Stem Cells in Adults With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03691909
- Acronym / sponsor ID
- HB-adMSCs / HBRA01
- Conditions
- Rheumatoid Arthritis
- Keywords
- arthritis, stem cells, MSCs, adipose MSCs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hope Biosciences LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2018 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 22 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hope Biosciences is conducting a research study of an investigational product called Hope Biosciences autologous adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as a possible treatment for Rheumatoid Arthritis (RA). The study purpose is to evaluate the safety profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.
Detailed description
This is a Phase 1/2a, open-label, single-dose study in subjects with active Rheumatoid Arthritis (RA). 12-15 patients will be enrolled for the study. The overall objective of this study is to evaluate the safety profile of a single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA. The primary endpoint of this study is to measure the number and frequency of adverse event(s) and/or severe adverse event(s) throughout the study duration. The second endpoint of this study is to evaluate the ability of HB-adMSCs to alter RA-related inflammation via measuring levels of Tumor Necrosis Factor alpha (TNF-a), Interleukin-6 (IL-6), C-Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR) and Joint Count 66/68 after a single infusion of autologous HB-adMSCs for up to 12-month post-infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: HB-adMSCsSingle IV administration of autologous adipose-derived mesenchymal stem cells Baseline laboratory data will be collected prior to infusion; follow up data will be compared against baseline at 1, 3, 6 and 12 months. Joint Assessment 68 will be administered at 1, 3, 6 and 12 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female between the ages of 18 and 65
- Patients have active RA as confirmed by the following criteria:
- Patients without current established treatment, or if being treated, patients who are on a stable dose of RA therapy regimen for ≥ 4 weeks prior to screening
Key exclusion criteria (10 listed)
- Inability to understand and provide signed informed consent
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 |
|---|---|---|
| HB-adMSCsHope Biosciences autologous adipose-derived mesenchymal stem cells | Biological | Treatment Arm |
Primary outcome
Total Number of Adverse Events and Serious Adverse Events
Time frame: 12 months
Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.
5 secondary outcomes
The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA
Time frame: 12 months
The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35241141Vij R, Stebbings KA, Kim H, Park H, Chang D. Safety and efficacy of autologous, adipose-derived mesenchymal stem cells in patients with rheumatoid arthritis: a phase I/IIa, open-label, non-randomized pilot trial. Stem Cell Res Ther. 2022 Mar 3;13(1):88. doi: 10.1186/s13287-022-02763-w.
- 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. This study is not recruiting at the moment.
Philip Waller, MD principal investigator
Accurate Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HB-adMSCs in people with Rheumatoid Arthritis, run by Hope Biosciences LLC at 1 site in United States.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Number of Adverse Events and Serious Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03691909, which also lists 1 linked publication.
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 26 Sep 2025.