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

August 28, 2017 updated by: Heba Mohamed Saad Eldien

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: stem cell, PRP
Adipose derived MSCs, versus Platelet rich plasma
Biological: Stem cell
after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells
Other Names:
  • PRP
Device: MSCs
manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells
Other Names:
  • Stem cell and PRP
Active Comparator: Stem cell, Stem cell and PRP
Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma
Biological: Stem cell
after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells
Other Names:
  • PRP
Device: MSCs
manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells
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)
Time Frame: 6 months
Patient Assessment Scar Scale
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heba Mohamed Saad Eldien

Collaborators

M.A. Eloteify
Ahmed Kamal Osman
G.M. Hafsa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCs, PRP, Scar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrophic Scar

Clinical Trials on Stem cell

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe