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

NCT04553159 | Completed Phase 2 DMC

• 1 other identifier: TASOREC/060/19-UG-REC-009
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Keloid; Autologus Adipose Derived Stem Cells; Feasibility; Safety

Keywords

Adipose derived stem cells; Keloids; Stromal vascular fraction

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Using the Common Terminology Criteria for Adverse events (CTCAE), we shall identify any treatment associated adverse events in both treatment arms and describe the nature and grade of the adverse events.

  three months

• The procedure time in hours.

  We intend to evaluate the time it will take to prepare and administer the treatment in both arms. The intervention arm involves three steps which are liposuction, lipo-aspirate processing as well as infiltration. We intend to evaluate the time this will take and compare it to the Active control arm which consists of one step which is the infiltration. This will help answer question on feasibility of performing this procedure as a day care procedure.

  three months

Study Arms (2)

Adipose Derived Stem Cell(ADSC) arm

EXPERIMENTAL

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).

Biological: Autologous adipose derived stem cells

Triamcinolone Acetanoide (TAC) arm

ACTIVE COMPARATOR

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.

Biological: Autologous adipose derived stem cells

Interventions

Autologous adipose derived stem cells BIOLOGICAL

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

Also known as: Adipose derived Stromal vasular fraction infiltration

Adipose Derived Stem Cell(ADSC) arm; Triamcinolone Acetanoide (TAC) arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Department of Surgery, Makerere University College of Health Sciences

Kampala, Uganda

Location

Related Publications (4)

• 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: 11807470 BACKGROUND

• 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: 29467010 BACKGROUND

• 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: 29799555 BACKGROUND

• 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: 28316259 BACKGROUND

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 17, 2020
• Study Start: March 1, 2021
• Primary Completion: June 16, 2021
• Study Completion: June 16, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)