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

Study Overview
=================
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.

Official Title
-----------------
Role of Stem Cells, Platelet Rich Plasma and Combination of Them in Treatment of Scars

Conditions
-----------------
Atrophic Scar

Intervention / Treatment
-----------------
* Biological: Stem cell
* Device: MSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: stem cell, PRP<br>Adipose derived MSCs, versus Platelet rich plasma | Biological: Stem cell<br>* after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells<br>* Other names: PRP;Device: MSCs<br>* manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells<br>* Other names: Stem cell and PRP;|
| Active Comparator: Stem cell, Stem cell and PRP<br>Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma | Biological: Stem cell<br>* after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells<br>* Other names: PRP;Device: MSCs<br>* manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells<br>* Other names: Stem cell and PRP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction (Patient Assessment Scar Scale) | Patient Assessment Scar Scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doctor satisfaction (Vancouver Scar Scale) | Vancouver Scar Scale (VSS) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrophic scar, PRP, ADSCs