Autologous Adipose Derived Stem Cells Transplantation in the Treatment of Keloids.
Condition: Keloid; Autologus Adipose Derived Stem Cells; Feasibility; Safety
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed 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
    

Intervention name(s): Autologous adipose derived stem cells
Intervention type(s): Biological
Intervention description(s): Once consented, tumescent liposuction will be performed and 100-300ml of lipoaspirate will be collected. The harvested lipoaspirate will be processed aseptically 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 immediate infiltration. cell counts and viability using Trypan blue will be perfomed prior to the infiltration
Other intervention name(s): Adipose derived Stromal vasular fraction infiltration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a pilot single centre randomized controlled trail with a ratio of 1:1 conducted in the Surgical out patient of Mulago Hospital Kampala
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adipose derived stem cells; Keloids; Stromal vascular fraction