NCT03264573

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

August 23, 2017

Last Update Submit

August 28, 2017

Conditions

Atrophic Scar

Keywords

Atrophic scarPRPADSCs

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction (Patient Assessment Scar Scale)

    Patient Assessment Scar Scale

    6 months

Secondary Outcomes (1)

  • Doctor satisfaction (Vancouver Scar Scale)

    6 months

Study Arms (2)

stem cell, PRP

ACTIVE COMPARATOR

Adipose derived MSCs, versus Platelet rich plasma

Biological: Stem cellDevice: MSCs

Stem cell, Stem cell and PRP

ACTIVE COMPARATOR

Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma

Biological: Stem cellDevice: MSCs

Interventions

Stem cellBIOLOGICAL

after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells

Also known as: PRP
Stem cell, Stem cell and PRPstem cell, PRP
MSCsDEVICE

manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells

Also known as: Stem cell and PRP
Stem cell, Stem cell and PRPstem cell, PRP

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 23, 2017

First Posted

August 29, 2017

Study Start

July 1, 2016

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08