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

Sponsor

Makerere University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04391621

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adipose Derived Stem Cells Keloid	Procedure: Autologous Adipose Derived stem cell transplantation Drug: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel group single centre randomised control pilot trial with a 1:1 ratio.Parallel group single centre randomised control pilot trial with a 1:1 ratio.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Keloid regression [3 months]
The Change in the volume of the keloid tissue in cubic centimetres.

Secondary Outcome Measures

The Patient and Observer Scar Assessment Scale(POSAS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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