Atrophic ScarNCT03264573
Role of Stem Cells, Platelet Rich Plasma in Treatment of Scars
A study testing Stem cell and MSCs in people with Atrophic Scar, run by Heba Mohamed Saad Eldien.
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. Read more about this study
- Who is it for?
- Ages 10 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Scar
- What is being tested?
- Stem cell and MSCs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient with atrophic scar.
- Age group: 5 years up to 35 years.
- No previous medications, surgeries or laser therapy.
Who cannot join
- Patient with hypertrophic or pigmented scar.
- Patient with any blood disease.
- Patients with lipodystrophy.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrophic Scar
- Being tested
- Stem cell, MSCs
- Keywords
- Atrophic scar, PRP, ADSCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cellBiological
Also called PRP
after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells
MSCsDevice
Also called Stem cell and PRP
manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| stem cell, PRP | Active comparator | Adipose derived MSCs, versus Platelet rich plasma Receives: Biological: Stem cell; Device: MSCs |
| Stem cell, Stem cell and PRP | Active comparator | Adipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma Receives: Biological: Stem cell; Device: MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction (Patient Assessment Scar Scale)
Patient Assessment Scar Scale
Measured: 6 months
Secondary outcomes (1)
Doctor satisfaction (Vancouver Scar Scale)
Vancouver Scar Scale (VSS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study startJul 2016
- Primary completionFeb 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heba Mohamed Saad Eldien
- Sponsor type
- University, hospital or other
- Collaborators
- M.A. Eloteify, Ahmed Kamal Osman, G.M. Hafsa
- Responsible party
- Sponsor-investigator, Heba Mohamed Saad Eldien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264573
- Sponsor's protocol ID
- MSCs, PRP, Scar
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Stem Cells, Platelet Rich Plasma and Combination of Them in Treatment of Scars
- ClinicalTrials.gov ID
- NCT03264573
- Acronym / sponsor ID
- MSCs, PRP, Scar
- Conditions
- Atrophic Scar
- Keywords
- Atrophic scar, PRP, ADSCs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heba Mohamed Saad EldienUniversity, hospital or other
- Collaborators
- M.A. Eloteify, Ahmed Kamal Osman, G.M. Hafsa
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| stem cell, PRP | Active comparator | Biological: Stem cell, Device: MSCsAdipose derived MSCs, versus Platelet rich plasma |
| Stem cell, Stem cell and PRP | Active comparator | Biological: Stem cell, Device: MSCsAdipose derived MSCs alone, other group is injected Adipose derived MSCs, and Platelet rich plasma |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient with atrophic scar.
- Age group: 5 years up to 35 years.
- No previous medications, surgeries or laser therapy.
Key exclusion criteria (3 listed)
- Patient with hypertrophic or pigmented scar.
- Patient with any blood disease.
- Patients with lipodystrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cellAlso: PRPafter scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells | Biological | Stem cell, Stem cell and PRP, stem cell, PRP |
| MSCsAlso: Stem cell and PRPmanual separation of platelets rich plasma and undifferentiated mesenchymal stem cells | Device | Stem cell, Stem cell and PRP, stem cell, PRP |
Primary outcome
Patient satisfaction (Patient Assessment Scar Scale)
Time frame: 6 months
Patient Assessment Scar Scale
1 secondary outcome
Doctor satisfaction (Vancouver Scar Scale)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Stem cell and MSCs in people with Atrophic Scar, run by Heba Mohamed Saad Eldien.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (Patient Assessment Scar Scale) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.