Skip to content

Fibroblast in Cutaneous Leishmaniasis

Investigation on Safety and Efficacy of Autologous Human Fibroblasts Transplantation in Regeneration of Atrophic Cutaneous Leishmaniasis Scar.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150715023218N1
Enrollment
5
Registered
2021-02-23
Start date
2021-03-21
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

Cutaneous Leishmaniasis. Cutaneous leishmaniasis

Interventions

Intervention group: Fibroblast Transplantation on number of 5 patients suffered from Cutaneous leishmaniasis to regenerate scar lesions after three subsequent fibroblast injections (2o mil/ turn) with

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Ages 15-65 Scar lesions caused by Cutaneous leishmaniasis grade 3 to 7; The willingness to provide informed consent for participation in the trial and the ability to communicate with the investigator during follow ups.

Exclusion criteria

Exclusion criteria: Use of Retinoids in the last 6 months Pregnancy Laser therapy in the last 6 months Cancer or any chronic systemic disease Chemical therapy Mesotherapy Active infection to Leishmaniasis in the scar Oragan or cell transplantation Autoimmune disease Breast feeding Dermal Filler in the last 6 months Plastic surgery at the site of Cutaneous leishmaniasis lesion Use of Corticosteroids Excessive exposure to sun. Subjects who are enrolled in any other clinical trial using systemic medication; or any other treatment that might interfere with this study Subjects with evidence of infection on area to be treated or elsewhere on body.

Design outcomes

Primary

MeasureTime frame
Dermal thickness. Timepoint: Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts. Method of measurement: Sonography.;Elasticity. Timepoint: Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts. Method of measurement: Cotometer.;Wound Diameter. Timepoint: Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts. Method of measurement: visioFace.

Secondary

MeasureTime frame
Patients Satisfaction. Timepoint: Before intervention, 2, 6 and 12 months after the third transplantation of Fibroblasts. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Faghihi

Iran University of Medical Sciences

faghihi.f@iums.ac.ir+98 21 8670 4722

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026