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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

HB-adMSCs

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring arthritis, stem cells, MSCs, adipose MSCs

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Accurate Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Total Number of Adverse Events and Serious Adverse Events

Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.

Secondary Outcome Measures

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.

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

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

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.

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.

Full Information

NCT ID

NCT03691909

First Posted

September 27, 2018

Last Updated

March 22, 2022

Sponsor

Hope Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT03691909

Brief Title

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

Acronym

HB-adMSCs

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 25, 2018 (Actual)

Primary Completion Date

August 17, 2020 (Actual)

Study Completion Date

September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hope Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

arthritis, stem cells, MSCs, adipose MSCs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

HB-adMSCs

Intervention Description

Hope Biosciences autologous adipose-derived mesenchymal stem cells

Primary Outcome Measure Information:

Title

Total Number of Adverse Events and Serious Adverse Events

Description

Total number of Adverse Events and Serious Adverse Events across all subjects over 12 months.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

The Effect of Single Injection of HB-adMSCs on TNF-a in Patients With Acute RA

Description

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.

Time Frame

12 months

Title

The Effect of Single Injection of HB-adMSCs on IL-6 in Patients With Acute RA

Description

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

Time Frame

12 months

Title

The Effect of Single Injection of HB-adMSCs on CRP in Patients With Acute RA

Description

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

Time Frame

12 months

Title

The Effect of Single Injection of HB-adMSCs on ESR in Patients With Acute RA

Description

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.

Time Frame

12 months

Title

The Effect of Single Injection of HB-adMSCs on Joint Count in Patients With Acute RA.

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Waller, MD

Organizational Affiliation

Accurate Clinical Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Accurate Clinical Research

City

Pasadena

State/Province

Texas

ZIP/Postal Code

77034

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35241141

Citation

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.

Results Reference

derived

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

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