Role of Stem Cells, Platelet Rich Plasma in Treatment of Scars

Not Applicable

Completed

• Conditions: Atrophic Scar
• Interventions: Biological: Stem cell; Device: MSCs

• Registration Number: NCT03264573
• Lead Sponsor: Heba Mohamed Saad Eldien

Brief Summary

The Objectives of this randomized controlled trial aiming to establishing a protocol of post scar revision care and to Study the effect of PRP and/or Adipose derived Mesenchymal Stem cell injection in improvement of atrophic scar after scar revision.

Detailed Description

Forty patients with atrophic scar since one to five years including 25 males and 15 females with ages ranging from ten to 35 years with main age of 22.68 will be divided into four groups each included ten patients. One group will be treated with scar revision only (control group or group I), 2nd group will be injected with PRP after scar revision, 3rd group will be injected with ADSCs after scar revision and the 4th group will be injected with a combination of PRP and ADSCs after scar revision. All groups were assisted pre-operative and six months post-operative. Complications, Scar width, Vancouver scar scale (VSS), surgeon assessment scar scale and patient assessment scar scale will be considered the outcome measurements.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2017-02
• Study Completion: 2017-07
• Status Verified: 2017-08
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-28
• Last Update Submitted: 2017-08-28
• Study First Posted: 2017-08-29
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patient with atrophic scar.
• Age group: 5 years up to 35 years.
• No previous medications, surgeries or laser therapy.

Exclusion Criteria

• Patient with hypertrophic or pigmented scar.
• Patient with any blood disease.
• Patients with lipodystrophy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stem cell, PRP	MSCs	Adipose derived MSCs, versus Platelet rich plasma
Stem cell, Stem cell and PRP	Stem cell	Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma
stem cell, PRP	Stem cell	Adipose derived MSCs, versus Platelet rich plasma
Stem cell, Stem cell and PRP	MSCs	Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma

Primary Outcome Measures

Name	Time	Method
Patient satisfaction (Patient Assessment Scar Scale)	6 months	Patient Assessment Scar Scale

Secondary Outcome Measures

Name	Time	Method
Doctor satisfaction (Vancouver Scar Scale)	6 months	Vancouver Scar Scale (VSS)