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A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Rheumatoid Arthritis (HB-adMSCs)

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ClinicalTrials.gov Identifier: NCT03691909
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hope Biosciences

Brief Summary:
Hope Biosciences is conducting a research study of an investigational product called 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
Active Rheumatoid Arthritis (RA) Biological: Hope Biosciences autologous mesenchymal stem cell therapy 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


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: Hope Biosciences autologous mesenchymal stem cell therapy HB-adMSCs
a single IV infusion of autologous adipose-derived mesenchymal stem cells (HB-adMSCs) in subjects with clinical diagnosis of RA.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 12 months ]
    All subjects entered into the study and exposed to the IV infusion will have detailed information collected on adverse events, serious adverse events and secondary organ damage for the overall safety analysis.


Secondary Outcome Measures :
  1. The effect of single inject 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 inject 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 inject 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/mL) during the trial

  4. The effect of single inject 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 eritrosedimentation rate (ESR) (mL/hr) during the trial.

  5. The effect of single inject 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.



Information from the National Library of Medicine

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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 and baseline (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 baseline.
    • 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 (3.5G/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.

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


Contacts
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Contact: Sherry Diers, RN (832)975-8840 Sherry@hope.bio

Locations
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United States, Texas
Accurate Clinical Research Recruiting
Pasadena, Texas, United States, 77034
Contact: Bradley Lamach    281-481-8557 ext 1    blamach@accurateclinicalresearch.com   
Principal Investigator: Amber Khan, MD         
Principal Investigator: Philip Waller, MD         
Sponsors and Collaborators
Hope Biosciences

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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT03691909     History of Changes
Other Study ID Numbers: HB-adMSCs for RA
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
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

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