Implantation of autologous peripheral mononuclear cells for leg ulcer in patients with collagen diseases (phase I study)

Implantation of autologous peripheral mononuclear cells for leg ulcer in patients with collagen diseases (phase I study) - Autologous peripheral mononuclear cells implantation for leg ulcer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002612

Enrollment

Registered

2009-10-10

Start date

2009-09-01

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

leg ulcer with collagen diseases

Interventions

1.0x107 cells per administration 3.0x107 cells per administration 1.0x108 cells per administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed as a collagen disease by the diagnostic criteria of each disease 2.Healthy volunteer who agreed to participate in writing

Exclusion criteria

Exclusion criteria: 1.Patients not standing the risk of extracorporeal circulation 2.Women on (possible) pregnancy or lactation 3.Adolescents judged inadequate by doctor in charge of the patient or the study

Design outcomes

Primary

Measure	Time frame
Improvement of leg ulcer at 4 weeks following the implantation of autologous peripheral mononuclear cells	—

Secondary

Measure	Time frame
1.Safety 2.Size of leg ulcer 3.Presence of symptoms regarding to leg ulcer 4.Blood flow	—

Countries

Japan

Contacts

Public ContactTani Katsuya

National Hospital Organization Awara Hospital Department of Pharmacy

nhoawara-secretary@umin.ac.jp0776-79-1211

Outcome results

None listed

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