Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis

Open-label trial of granulocyte-colony stimulating factor (G-CSF) for evaluating efficacy on peripheral vascular disease in patients with systemic sclerosis - Open-label trial of G-CSF on systemic sclerosis-related peripheral vascular disease

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000589

Enrollment

Registered

2007-02-14

Start date

2007-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

systemic sclerosis (SSc)

Interventions

Granulocyte-colony stimulating factor (G-CSF), &quot

Gran&quot

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with digital ulcers resistant to conventional therapies including prostanoids Written informed consent must be obtained.

Exclusion criteria

Exclusion criteria: Medical history of allergic reactions to G-CSF derivation or other recombinant proteins produced in E.coli Patient diagnosed as having myeloid leukemia, myelodysplastic syndrome and other hematopoietic malignancies Patient with severe liver, renal, and/or cardio-respiratory dysfunctions Patient with severe splenomegaly Patient with thrombopenia ( <100,000 / microliter) Medical history of thromboembolism ( cerebrovascular disease, ishemic heart disease, deep vein thrombosis, pulmonary thromboembolism )

Design outcomes

Primary

Measure	Time frame
Digital ulcers at the 24 weeks	—

Secondary

Measure	Time frame
The number of circulating endothelial precursors in the peripheral blood, Raynaud's core set, safety	—

Countries

Japan

Contacts

Public ContactMasataka Kuwana

Keio University School of Medicine Department of Internal Medicine

kuwanam@z5.keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026