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

NCT ID: NCT03264573

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Atrophic Scar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cell, PRP

Adipose derived MSCs, versus Platelet rich plasma

Group Type ACTIVE_COMPARATOR

Stem cell

Intervention Type BIOLOGICAL

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

MSCs

Intervention Type DEVICE

manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells

Stem cell, Stem cell and PRP

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

Group Type ACTIVE_COMPARATOR

Stem cell

Intervention Type BIOLOGICAL

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

MSCs

Intervention Type DEVICE

manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells

Interventions

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Stem cell

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

Intervention Type BIOLOGICAL

MSCs

manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells

Intervention Type DEVICE

Other Intervention Names

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PRP Stem cell and PRP

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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M.A. Eloteify

UNKNOWN

Sponsor Role collaborator

Ahmed Kamal Osman

UNKNOWN

Sponsor Role collaborator

G.M. Hafsa

UNKNOWN

Sponsor Role collaborator

Heba Mohamed Saad Eldien

OTHER

Sponsor Role lead

Responsible Party

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Heba Mohamed Saad Eldien

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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MSCs, PRP, Scar

Identifier Type: -

Identifier Source: org_study_id

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