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

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ClinicalTrials.gov Identifier: NCT04391621
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Makerere University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. Keloid regression [ Time Frame: 3 months ]
    The Change in the volume of the keloid tissue in cubic centimetres.


Secondary Outcome Measures :
  1. The Patient and Observer Scar Assessment Scale(POSAS) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391621


Contacts
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Contact: Ronald Mbiine, First +256774338585 mbiineron@gmail.com
Contact: Moses Galukande, Second +256 772 410 503 galukand@gmail.com

Locations
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Uganda
Department of Surgery, Makerere University College of Health Sciences
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Publications of Results:
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT04391621    
Other Study ID Numbers: REC REF 2020-086
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will share the IPD only on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Makerere University:
Keloids
Adipose stem cells
Stem cells
Scars
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action