Efficacy of Adipose Derived Stromal Vascular Fraction 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: NCT04391621|
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : June 16, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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.|
|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|
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.
- Keloid regression [ Time Frame: 3 months ]The Change in the volume of the keloid tissue in cubic centimetres.
- 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.
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
|Contact: Ronald Mbiine, Firstfirstname.lastname@example.org|
|Contact: Moses Galukande, Second||+256 772 410 email@example.com|
|Department of Surgery, Makerere University College of Health Sciences|