NCT04391621

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

October 8, 2019

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

October 8, 2019

Last Update Submit

June 16, 2021

Conditions

Adipose Derived Stem CellsKeloid

Keywords

KeloidsAdipose stem cellsStem cellsScars

Outcome Measures

Primary Outcomes (1)

  • Keloid regression

    The Change in the volume of the keloid tissue in cubic centimetres.

    3 months

Secondary Outcomes (1)

  • The Patient and Observer Scar Assessment Scale(POSAS)

    3 months

Study Arms (2)

Adipose Derived Stem Cell(ADSC) arm

EXPERIMENTAL

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

Triamcinolone Acetanoide (TAC) arm

ACTIVE COMPARATOR

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

Interventions

Autologous Adipose Derived stem cell transplantationPROCEDURE

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.

Also known as: Stromal vasular fraction infiltration
Adipose Derived Stem Cell(ADSC) arm
Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1DRUG

Triamcinolone Acetanoide 40mg/ml suspension will be diluted into 1ml of 0.5% lignocaine solution and infiltrated into the selected keloid.

Triamcinolone Acetanoide (TAC) arm

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, Makerere University College of Health Sciences

Kampala, Uganda

RECRUITING

Kiruddu National Referral Hospital

Kampala, Uganda

RECRUITING

Related Publications (7)

  • Shaffer JJ, Taylor SC, Cook-Bolden F. Keloidal scars: a review with a critical look at therapeutic options. J Am Acad Dermatol. 2002 Feb;46(2 Suppl Understanding):S63-97. doi: 10.1067/mjd.2002.120788.

    PMID: 11807470RESULT

  • Davidson S, Aziz N, Rashid RM, Khachemoune A. A primary care perspective on keloids. Medscape J Med. 2009;11(1):18. Epub 2009 Jan 20.

    PMID: 19295939RESULT

  • Rockwell WB, Cohen IK, Ehrlich HP. Keloids and hypertrophic scars: a comprehensive review. Plast Reconstr Surg. 1989 Nov;84(5):827-37. doi: 10.1097/00006534-198911000-00021. No abstract available.

    PMID: 2682703RESULT

  • Wang X, Ma Y, Gao Z, Yang J. Human adipose-derived stem cells inhibit bioactivity of keloid fibroblasts. Stem Cell Res Ther. 2018 Feb 21;9(1):40. doi: 10.1186/s13287-018-0786-4.

    PMID: 29467010RESULT

  • Lee G, Hunter-Smith DJ, Rozen WM. Autologous fat grafting in keloids and hypertrophic scars: a review. Scars Burn Heal. 2017 Apr 6;3:2059513117700157. doi: 10.1177/2059513117700157. eCollection 2017 Jan-Dec.

    PMID: 29799555RESULT

  • Ramakrishnan VM, Boyd NL. The Adipose Stromal Vascular Fraction as a Complex Cellular Source for Tissue Engineering Applications. Tissue Eng Part B Rev. 2018 Aug;24(4):289-299. doi: 10.1089/ten.TEB.2017.0061. Epub 2017 Apr 13.

    PMID: 28316259RESULT

  • Fan D, Xia Q, Wu S, Ye S, Liu L, Wang W, Guo X, Liu Z. Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial. Trials. 2018 Mar 2;19(1):155. doi: 10.1186/s13063-018-2478-x.

    PMID: 29499740RESULT

MeSH Terms

Conditions

KeloidCicatrix

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Central Study Contacts

Ronald Mbiine, First

CONTACT

+256774338585mbiineron@gmail.com

Moses Galukande, Second

CONTACT

+256 772 410 503galukand@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The patients, investigators and outcome assessors will be blinded from the treatment allocation groups. The treatment groups will be recorded such that the assessors will be unaware of the treatment allocations that the participants were involved.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group single centre randomised control pilot trial with a 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

May 18, 2020

Study Start

May 1, 2021

Primary Completion

December 30, 2021

Study Completion

December 31, 2023

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Will share the IPD only on request.

Locations

UG(2)