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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: HB-adMSCs

• Registration Number: NCT03691909
• Lead Sponsor: Hope Biosciences

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.

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 Timeline

• Study Start: 2018-09-25
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Primary Completion: 2020-08-17
• Study Completion: 2020-09-28
• Results First Submitted: 2021-08-19
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-24
• Results First Posted: 2022-03-22
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	HB-adMSCs	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.

Primary Outcome Measures

Name	Time	Method
Total Number of Adverse Events and Serious Adverse Events	12 months	Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.

Secondary Outcome Measures

Name	Time	Method
The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA	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
The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA	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.
The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.	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.
The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA	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
The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA	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.

Trial Locations

Locations (1)

Accurate Clinical Research; 🇺🇸 Pasadena, Texas, United States