RECRUITING

HB-adMSCs vs Placebo for the Treatment of Juvenile Idiopathic Arthritis

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Conditions

Juvenile Idiopathic Arthritis (JIA)JIAjuvenile idiopathic arthritisjuvenile arthritisoligoarticularpolyarticularpolyarticular juvenile idiopathic arthritisoligoarticular juvenile idiopathic arthritisarthritis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Methodology: Randomized, double-blind, AB/BA cross-over study with a washout period of 12 weeks. Treatment Duration: 8 weeks per group General Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of juvenile idiopathic arthritis in this subject population. Number of Subjects: 66 (6 subjects in Cohort 1 and 60 subjects in Cohort 2) Indication: Juvenile Idiopathic Arthritis

Official Title

A Randomized, Double-Blind, Phase 2, Efficacy and Safety Cross-Over Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Oligoarticular and Polyarticular Juvenile Idiopathic Arthritis

Quick Facts

Study Start:2025-03
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06623240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female subjects who are ≥ 2 years old and \< 17 years old.
  2. 2. Must be diagnosed with Oligoarticular or Polyarticular Juvenile Idiopathic Arthritis by a Pediatric Rheumatologist.
  3. 3. Must have rheumatoid factor (RF) factor test result documented in medical records.
  4. 4. Must have at least 3 affected joints at the screening visit.
  5. 5. Must have a body weight of \> 10 kg at the screening visit.
  6. 6. Subjects without a current established treatment for JIA who are not on treatment because they have failed at least 2 approved medications for their condition, or if being treated, subjects who are on a stable dose of arthritis therapy regimen for ≥3 months prior to screening.
  7. 7. Must have an abnormal CRP result and/or abnormal ESR result at screening. Abnormal C-reactive protein (CRP) value defined as \> 1 mg/dL. Abnormal Erythrocyte Sedimentation Rate (ESR) value defined as \>15 mm/hr for males and \>20 mm/hr for females.
  8. 8. Female study subjects of childbearing potential should not be pregnant or plan to become pregnant during study participation and for 6 months after the last investigational product administration. Female study subjects of childbearing potential must confirm usage of one of the following contraceptive measures:
  9. * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
  10. * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
  11. * Barrier contraceptive methods (condoms, diaphragm, etc.).
  12. 9. Male subjects if their sexual partners can become pregnant should ensure the use one of the following methods of contraception during study participation and for 6 months after the last administration of the investigated product.
  13. * Hormonal contraceptives associated with ovulation inhibition (oral, injectable, implantable, patch, or intravaginal).
  14. * Intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).
  15. * Barrier contraceptive methods (condoms, diaphragm, etc.).
  16. 10. Study subject's parent(s)/LAR is/are able and willing to comply with the requirements of this clinical trial.
  17. 11. Voluntarily signed informed consent from study subjects' parent(s) or legally authorized representative obtained before any clinical-trial related procedures are performed.
  1. 1. Study subject has any of the following laboratory results at the screening visit:
  2. 1. WBC: \<3000 cells/μL OR \>15000 cells/μL (\<3 K cells/μL or \>15 K cells/μL)
  3. 2. Hemoglobin: \<8 g/dL
  4. 3. Absolute Neutrophil Count: \<1500 cells/μL
  5. 4. Platelet: \<150000 cells/μL (\<150 K cells/μL)
  6. 5. Sodium: \<120 mEq/L OR \>150 mEq/L
  7. 6. Glucose: \>150 mg/dL
  8. 7. Potassium: \<3.5 mEq/L OR \>6 mEq/L
  9. 8. BUN: \>25 mg/dL
  10. 9. Creatinine: \>2 mg/dL
  11. 10. BUN/Creatinine ratio: \>50
  12. 11. AST: \>100 U/L
  13. 12. ALT: \>100 U/L
  14. 2. Study participant has any vital sign abnormalities at the screening visit as determined by the investigator.
  15. 3. Study subject has 1 or more significant uncontrolled concurrent medical conditions (verified by medical records), including the following:
  16. 1. Diabetes Mellitus
  17. 2. Crohn's Disease
  18. 3. Lupus
  19. 4. Multiple Sclerosis
  20. 4. Study subject has any active malignancy, including evidence of cutaneous basal, squamous cell carcinoma or melanoma.
  21. 5. Study subject has known alcoholic addiction or dependency or has current substance use or abuse.
  22. 6. Study subject has received any stem cell treatment within 1 year before first dose of investigational product other than stem cells produced by Hope Biosciences LLC.
  23. 7. Receiving any investigational therapy or any approved therapy for investigational use within 1 year prior first dose of the investigational product other than COVID-19 vaccines.
  24. 8. Study subject has any other laboratory abnormality or medical condition which, in the opinion of the investigator, poses a safety risk or will prevent the subject from completing the study.
  25. 9. Study subject's parent(s)/LAR unable to understand and provide signed informed consent.
  26. 10. Study subject and/or study subject's parent(s)/LAR unlikely to complete the study or adhere to the study procedures.
  27. 11. Study subject with known concurrent acute or chronic viral hepatis B or C or human immunodeficiency virus (HIV) infection.
  28. 12. Study subject with any systemic infection requiring treatment with antibiotics, antivirals, or antifungals within 30 days prior to first dose of the investigational product.

Contacts and Locations

Study Contact

David Gonzalez
CONTACT
346-900-0340
david@hopebio.org
Michelle Biedron
CONTACT
346-900-0340
michelle@hopebio.org

Principal Investigator

Thanh Cheng, MD
PRINCIPAL_INVESTIGATOR
Hope Biosciences Research Foundation

Study Locations (Sites)

Hope Biosciences Research Foundation
Sugar Land, Texas, 77478
United States

Collaborators and Investigators

Sponsor: Hope Biosciences

  • Thanh Cheng, MD, PRINCIPAL_INVESTIGATOR, Hope Biosciences Research Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-03
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • JIA
  • juvenile idiopathic arthritis
  • juvenile arthritis
  • oligoarticular
  • polyarticular
  • polyarticular juvenile idiopathic arthritis
  • oligoarticular juvenile idiopathic arthritis
  • arthritis

Additional Relevant MeSH Terms

  • Juvenile Idiopathic Arthritis (JIA)