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Phase 1/2a Clinical Trial to Assess the Safety of HB-adMSCs for the Treatment of Rheumatoid Arthritis (HB-adMSCs)

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ClinicalTrials.gov Identifier: NCT03691909
Recruitment Status : Completed
First Posted : October 2, 2018
Results First Posted : March 22, 2022
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Hope Biosciences

Study Description
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Brief 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). The study purpose is to evaluate the safety profile of a single IV infusion of HB-adMSCs in subjects with clinical diagnosis of RA.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: HB-adMSCs Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : September 25, 2018
Actual Primary Completion Date : August 17, 2020
Actual Study Completion Date : September 28, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
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.
 Biological: HB-adMSCs
Hope Biosciences autologous adipose-derived mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA [ Time Frame: 12 months ]
    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.

  2. The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA [ Time Frame: 12 months ]
    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

  3. The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA [ Time Frame: 12 months ]
    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

  4. The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA [ Time Frame: 12 months ]
    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.

  5. The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA. [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
      • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691909


Locations
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United States, Texas
Accurate Clinical Research
Pasadena, Texas, United States, 77034
Sponsors and Collaborators
Hope Biosciences
Investigators
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Principal Investigator: Philip Waller, MD Accurate Clinical Research
  Study Documents (Full-Text)

Documents provided by Hope Biosciences:
Study Protocol  [PDF] September 24, 2019
Statistical Analysis Plan  [PDF] November 10, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT03691909    
Other Study ID Numbers: HBRA01
First Posted: October 2, 2018    Key Record Dates
Results First Posted: March 22, 2022
Last Update Posted: March 31, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hope Biosciences:
arthritis
stem cells
MSCs
adipose MSCs
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases