Autologous Adipose Derived Stem Cells Transplantation in the Treatment of Keloids.

Makerere University

Status and phase: Completed; Phase 2

Conditions: Keloid; Feasibility; Autologus Adipose Derived Stem Cells; Safety

Treatments: Biological: Autologous adipose derived stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04553159

TASOREC/060/19-UG-REC-009

Details and patient eligibility

About

Keloids are the most common disfiguring skin disorder affecting colored population with a prevalence of upto 16%.

Autologous adipose derived stem cells have been found to have potential therapeutic benefits however limited clinical trials have compared there role to standard therapy.

This is a pilot study that is intended to evaluate the feasibility of conducting this clinical trial comparing adipose derived stromal vascular fraction to Triamcinolone in keloid treatment. The full clinical trial is already registered under the clinical trial number NCT04391621.

The objective of this Pilot is to evaluate the feasibility of conducting a full study on the same topic.

Full description

Background: Keloids affect upto 16% of Africans and often demonstrate more aggressive behaviour with poor response to existing therapies.

Adipose derived stem cells have been described to have inhibitory effects on keloid growth with several invitro studies and case series reporting promising findings.

Despite this knowledge, no clinical trial has been conducted to compare the efficacy of these adipose derived stem cells to existing standard therapy. We intend to conduct a clinical trial comparing the adipose derived stem cells to the existing standard of care here in Uganda which is Triamcinolone Acetanoide a trial that is registered under the clinical trial number NCT04391621. Before scaling up this study, we intend to evaluate the feasibility to conducting a full scale study by first piloting the same trial to a smaller number of participants.

The primary objective of this study will be to describe the feasibility and safety of adipose derived stem cells in the treatment of keloids as well as to document the process of autologous adipose derived stem cells harvesting and processing. The secondary outcome will be the clinical endpoints of keloid regression and symptom relief at the end of one month.

This will be a pilot parallel and un-blinded randomised controlled trial that will be conducted at Mulago National Referral Hospital. 6 patients will be allocated randomly into either Triamcinolone group and Adipose Derived Stem cells group. Each arm will receive the respective single dose infiltration of the selected treatment.

The patients will be followed up for three months for keloid regression and symptom relief as well as development of side effects.

Utility: This pilot study is intended to evaluate the feasibility of conducting a clinical trial on the efficacy of Autologous adipose derived stem cells in the treatment of keloids

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Adipose Derived Stem Cell(ADSC) arm

Experimental group

Description:

Participants allocated to this arm will have tumescent liposuction performed on them to obtain lipoaspirate. The lipoaspirate will then be processed to obtain the stromal vascular fraction. This Adipose derived stromal vascular fraction which contains stem cells will then be infiltrated into the keloid tissue as a single dose 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).

Treatment:

Biological: Autologous adipose derived stem cells

Triamcinolone Acetanoide (TAC) arm

Active Comparator group

Description:

Participants in this arm will receive a single dose Triamcinolone acetanoide infiltration into the keloid. This will be a single dose infiltration of 40mg/cubic centimetres of keloids.

Treatment:

Biological: Autologous adipose derived stem cells