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

Primary Purpose

Atrophic Scar

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stem cell
MSCs
Sponsored by
Heba Mohamed Saad Eldien
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrophic Scar focused on measuring Atrophic scar, PRP, ADSCs

Eligibility Criteria

10 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    stem cell, PRP

    Stem cell, Stem cell and PRP

    Arm Description

    Adipose derived MSCs, versus Platelet rich plasma

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

    Outcomes

    Primary Outcome Measures

    Patient satisfaction (Patient Assessment Scar Scale)
    Patient Assessment Scar Scale

    Secondary Outcome Measures

    Doctor satisfaction (Vancouver Scar Scale)
    Vancouver Scar Scale (VSS)

    Full Information

    First Posted
    August 23, 2017
    Last Updated
    August 28, 2017
    Sponsor
    Heba Mohamed Saad Eldien
    Collaborators
    M.A. Eloteify, Ahmed Kamal Osman, G.M. Hafsa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03264573
    Brief Title
    Role of Stem Cells, Platelet Rich Plasma in Treatment of Scars
    Official Title
    Role of Stem Cells, Platelet Rich Plasma and Combination of Them in Treatment of Scars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Heba Mohamed Saad Eldien
    Collaborators
    M.A. Eloteify, Ahmed Kamal Osman, G.M. Hafsa

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrophic Scar
    Keywords
    Atrophic scar, PRP, ADSCs

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    stem cell, PRP
    Arm Type
    Active Comparator
    Arm Description
    Adipose derived MSCs, versus Platelet rich plasma
    Arm Title
    Stem cell, Stem cell and PRP
    Arm Type
    Active Comparator
    Arm Description
    Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma
    Intervention Type
    Biological
    Intervention Name(s)
    Stem cell
    Other Intervention Name(s)
    PRP
    Intervention Description
    after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells
    Intervention Type
    Device
    Intervention Name(s)
    MSCs
    Other Intervention Name(s)
    Stem cell and PRP
    Intervention Description
    manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells
    Primary Outcome Measure Information:
    Title
    Patient satisfaction (Patient Assessment Scar Scale)
    Description
    Patient Assessment Scar Scale
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Doctor satisfaction (Vancouver Scar Scale)
    Description
    Vancouver Scar Scale (VSS)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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