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

Atrophic Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264573
• Other study ID #: MSCs, PRP, Scar
• Status: Completed
• Phase: N/A
• First received: August 23, 2017
• Last updated: August 28, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophic Scar
• Atrophy

Intervention

Biological:
• Stem cell
after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells

Device:
• MSCs
manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Heba Mohamed Saad Eldien	Ahmed Kamal Osman, G.M. Hafsa, M.A. Eloteify

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction (Patient Assessment Scar Scale)	Patient Assessment Scar Scale	6 months
Secondary	Doctor satisfaction (Vancouver Scar Scale)	Vancouver Scar Scale (VSS)	6 months