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Investigating the safety and efficacy of injection of fat tissue cells in patients with scleroderma

Investigating the safety and efficacy of intradermal stromal vascular fraction cells injection of autologous fat tissue in patients with scleroderma (clinical, biometric and laboratory evaluation): Phase I and II clinical study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200127046282N35
Enrollment
18
Registered
2024-05-25
Start date
2024-06-04
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

scleroderma. Systemic sclerosis [scleroderma]

Interventions

Intervention 1: Intervention group: Patients will undergo a single injection of 5 cc of SVF cells (20 million cells) at the lesion site. Intervention 2: Control group: Patients will undergo a single i

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The patient is suffering from scleroderma and has been diagnosed by a doctor. The patient has skin involvement in the fingers or face. The patient is in the stable phase of the disease, which is confirmed by the attending physician. The patient has the desire to perform the mentioned procedure.

Exclusion criteria

Exclusion criteria: having infectious diseases.

Design outcomes

Primary

MeasureTime frame
Qualitative intensity of scleroderma. Timepoint: Before treatment and 3 months after treatment. Method of measurement: Patient complaint, objective evaluation by a physician.

Secondary

MeasureTime frame
Quantitative intensity of scleroderma. Timepoint: Before treatment, three months after treatmen. Method of measurement: Determine the size of the lesions with visioface, determine the location and number of lesions.;The rate of improvement of scleroderma. Timepoint: Before treatment, three months after treatment. Method of measurement: Patient satisfaction, visioface photography, physician diagnosis.;Adverse events. Timepoint: Before treatment, three months after treatment. Method of measurement: Patient report, Physician diagnosis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSona Zare

Skin and Stem cell Research Center of Tehran University of Medical Sciences

sonazarebio@gmail.com+98 21 2665 7438

Outcome results

None listed

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