Efficacy of Adipose Derived Stromal Vascular Fraction in the Treatment of Keloids

June 16, 2021 updated by: Makerere University

Efficacy of Autologous Adipose Derived Stromal Vascular Fraction in the Treatment of Keloids

Keloids affect upto 16% of Africans causing significant cosmetic, functional and psychosocial distress. Available treatment options are associated with high recurrence and highly variable symptom relief. Autologous adipose derived stem-cells(ADSCs) have been described to have a potential therapeutic benefit in treating keloids. Investigators will compare intra-lesion single dose Autologous Adipose Derived Stem Cells harvested from abdominal fat to Triamcinolone Acetanoide among 15 patients with keloids treated at Mulago National Referral Hospital in Kampala Uganda between September 2020 and August 2021. These patients will be followed up for keloid volume change at three months following treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: Keloids are a disorder of wound healing characterized with excessive scar formation affecting upto 16% of Africans. These are often associated with functional and cosmetic disfigurement with resultant psychosocial distress and reduced quality of life.

Available treatment options are associated with high recurrence and highly variable symptom relief. Autologous Adipose Derived Stem cells (ADSCs) have been recognized to have effect on scar remodeling including regression and remission thus becoming a promising alternative novel therapy. Investigators hypothesize that these ADSCs have a comparable efficacy to Triamcinolone Acetanoide (TAC) which is the existing standard of care in sub-Saharan Africa and therefore intend to evaluate the efficacy and acceptability of ADSCs as a therapy in the treatment of keloids. More specifically they shall evaluate the efficacy and acceptability of ADSCs versus TAC in non-surgical treatment of keloids as well as the efficacy of ADSCs to TAC as post-surgical excision adjuvant therapy in preventing recurrence.

Methods: Investigators shall conduct a single center parallel randomized control trial at Mulago National Referral Hospital following the approval of the Research Ethics Committee of SOM-MakCHS.

For the intervention arm, ADSCs will be obtained by processing lipoaspirate obtained from the abdominal fat-pad of the participants. The control arm will receive TAC. Both arms will receive intra-lesional infiltration of either treatments and followed up at 3 months after therapy. The primary outcome will be the scar regression, remission and acceptability. Two-way Repeated Measures Anova will be used to determine the difference in the treatment arms and time. The All Pair Wise Multiple Comparison Procedure (Holm-Sidak method) will be used to determine the specific differences for both time and treatment factors with an alpha gain set at 0.05.

Potential impact: This project promises to introduce Adipose Derived Stem-cells as a readily available alternative or adjuvant to existing therapies for keloids.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Kiruddu National Referral Hospital
        • Contact:
        • Contact:
      • Kampala, Uganda
        • Recruiting
        • Department of Surgery, Makerere University College of Health Sciences
        • Contact:
        • Contact:

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a single keloid of 1-2cm3 as these have the highest response to any treatment administered.

Exclusion Criteria:

  • Previous intra-lesional steroid injection treatment in the last three months as the effects may still be ongoing
  • Insufficient abdominal fat pad(depth) of 3cm
  • Confirmed bleeding disorder
  • Ongoing systemic illness
  • Ulceration or local keloid infection

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adipose Derived Stem Cell(ADSC) arm
In this arm, the participant selected keloid will receive a single dose intra-lesional Adipose derived Stem cells infiltration. This will be harvested and infiltrated as the whole cell pellet (stromal vascular fraction) comprising of an estimate total of 9 million ADSCs (range: 8.4-9.72; SD ± 6.6).
Procedure: Autologous Adipose Derived stem cell transplantation
Through liposuction, harvested lipoaspirate will be processed in theatre through centrifugation at 1200g, then the sediment will be washed with Phosphate buffered saline and then incubated at 37 degrees celsius in 0.075% Collagenase type 1a for 1 hour. This will then be washed in an equal volume of 10% Fetal Bovine Serum then filtered through a 100 micrometer cell strainer. Red cells lysed using the Red cell lysis buffer will be performed followed by washing in Phosphate buffered Saline and centrifugation and the stromal vascular fraction cell pellet collected and diluted into 5ml normal saline solution for inflitration. This will then be infiltrated into the affected keloid.
Other Names:
  • Stromal vasular fraction infiltration
Active Comparator: Triamcinolone Acetanoide (TAC) arm

This arm will receive a single dose Triamcinolone acetanoide infiltration into the keloid.

This will be a single dose infiltration of 40mg/cubic centimetres.
Drug: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
Triamcinolone Acetanoide 40mg/ml suspension will be diluted into 1ml of 0.5% lignocaine solution and infiltrated into the selected keloid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keloid regression
Time Frame: 3 months
The Change in the volume of the keloid tissue in cubic centimetres.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Patient and Observer Scar Assessment Scale(POSAS)
Time Frame: 3 months
The pre-treatment and post treatment Patient and Observer Scar Assessment Scale (POSAS) score of the participants will be determined. This is a 10 point score in 1 corresponds to a scar equivalent to normal skin while 10 to the worst possible scar quality. The scar is compared to normal skin at a comparable anatomic site whenever possible.
3 months

Collaborators and Investigators

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

Sponsor

Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 1, 2021

Primary Completion (Anticipated)

December 30, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 8, 2019

First Submitted That Met QC Criteria

May 12, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC REF 2020-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will share the IPD only on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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