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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553159
Recruitment Status : Not yet recruiting
First Posted : September 17, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Makerere University

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.


Condition or disease Intervention/treatment Phase
Keloid Autologus Adipose Derived Stem Cells Feasibility Safety Biological: Autologous adipose derived stem cells Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
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
Official Title: Autologous Adipose Derived Stem Cell Transplantation in the Treatment of Keloids. A Pilot Randomized Controlled Trial
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 31, 2021

Arm Intervention/treatment
Experimental: Adipose Derived Stem Cell(ADSC) arm

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
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 Name: Adipose derived Stromal vasular fraction infiltration

Active Comparator: Triamcinolone Acetanoide (TAC) arm
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
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 Name: Adipose derived Stromal vasular fraction infiltration




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: three months ]
    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.

  2. The procedure time in hours. [ Time Frame: three months ]

    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.



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

  2. The Patient and Observer Scar Assessment Scale(POSAS) [ Time Frame: Three 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:   Yes
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): NCT04553159


Locations
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Uganda
Department of Surgery, Makerere University College of Health Sciences
Kampala, Uganda
Sponsors and Collaborators
Makerere University
Publications:
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT04553159    
Other Study ID Numbers: TASOREC/060/19-UG-REC-009
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We don't intend to share individual participant data to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Makerere University:
Adipose derived stem cells
Keloids
Stromal vascular fraction
Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes