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NCT07845942From ClinicalTrials.govRecruiting

Allogeneic Hematopoietic Cell Transplantation for Refractory Systemic Juvenile Idiopathic Arthritis.

Allogeneic Hematopoietic Cell Transplantation for Refractory Systemic Juvenile Idiopathic Arthritis: A Single-Center Prospective Trial

  • Refractory Systemic Juvenile Idiopathic Arthritis
  • Systemic Juvenile Idiopathic Arthritis
  • Systemic Juvenile Idiopathic Arthritis Associated Lung Disease

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrolment target
20
Started
November 2026
Main results due
July 2031
Study sites
1
Registry updated
29 September 2026

Can you take part?

  • Up to 35 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Patients \<35 years of age are eligible, and participants must meet all the following criteria to be eligible for this study:
* Diagnosis: Systemic Juvenile Idiopathic Arthritis (sJIA) diagnosed prior to age 16, fulfilling ILAR classification criteria for sJIA or the provisional PRINTO criteria for systemic arthritis. The diagnosis and disease course must be reviewed and confirmed by a pediatric rheumatologist.
* Refractory Disease: sJIA that is refractory to standard therapy, defined as meeting at least one of these conditions despite appropriate treatment:
* Persistent JIA activity: Ongoing active disease (e.g. uncontrolled arthritis or systemic features such as fever, rash, organ inflammation) or progressive joint damage or liver dysfunction that has not responded to biologic agents (IL-1/IL-6 inhibitors) and conventional therapies, or inability to wean from high-dose corticosteroids (steroid dependence).
* Recurrent MAS: Two or more episodes of macrophage activation syndrome within a 2-year period, indicating a failure to control the hyperinflammation with medical management. (MAS is defined by clinical and laboratory criteria such as fever, cytopenias, hyperferritinemia, hemophagocytosis, etc., per standard definitions.)
* sJIA-LD: Presence of lung disease related to sJIA, either symptomatic LD (e.g. chronic cough, tachypnea, hypoxemia) or progressive LD on imaging (worsening interstitial changes), meeting clinical/imaging features such as patchy ground-glass opacities, septal and pleural thickening, or clubbing of digits. sJIA-LD should be confirmed by a pulmonologist/radiologist (e.g. HRCT findings).

Exclusion Criteria:

* Uncontrolled Infection: Presence of a severe, uncontrolled infection at time of enrollment (e.g. sepsis, pneumonia not responding to therapy).
* Significant Organ Failure:
* Cardiac: EF \< 40%
* Renal: GFR \< 30 ml/hr
* Active Malignancy: Concurrent cancer diagnosis or history of malignant disease requiring active treatment.
* Pregnancy or Lactation: Female patients who are pregnant or breastfeeding. Female participants of childbearing potential must have a negative pregnancy test clinical result at screening (pregnancy testing is done as standard of care for all transplant patients).

What this study is about

In the sponsor’s own words, from the registry.

The goal of this study is to collect clinical data and samples and to evaluate the feasibility of allogeneic hematopoietic cell transplantation (HCT) in children and young adults with refractory Systemic Juvenile Idiopathic Arthritis (sJIA), including those with sJIA-associated lung disease (sJIA-LD).

Study sites(1)

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, United States

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07845942. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Allogeneic Hematopoietic Cell Transplantation for Refractory Systemic Juvenile Idiopathic Arthritis. | Trialion