Efficacy of Adipose Derived Stromal Vascular Fraction in the Treatment of Keloids
NCT ID: NCT04391621
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2021-05-01
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Autologous Adipose Derived Stem Cells Transplantation in the Treatment of Keloids.
NCT04553159
Implantation of Mesenchymal Stem Cell, Conditioned Medium, or Triamcinolone Acetonide for Keloid
NCT04326959
Post-Surgical Injection With Triamcinolone Versus Triamcinolone/Fluorouracil in Treatment of Keloids
NCT04710719
Efficacy and Safety of Fractional CO2 Laser Combined With Intralesional Insulin, Botulinum Toxin or Triamcinolone Acetonide in the Treatment of Keloid: A Clinical, Dermoscopic and Immunohistochemical Study.
NCT06230146
The Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment
NCT06814288
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Insufficient abdominal fat pad(depth) of 3cm
* Confirmed bleeding disorder
* Ongoing systemic illness
* Ulceration or local keloid infection
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Makerere University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Surgery, Makerere University College of Health Sciences
Kampala, , Uganda
Kiruddu National Referral Hospital
Kampala, , Uganda
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Davidson S, Aziz N, Rashid RM, Khachemoune A. A primary care perspective on keloids. Medscape J Med. 2009;11(1):18. Epub 2009 Jan 20.
Rockwell WB, Cohen IK, Ehrlich HP. Keloids and hypertrophic scars: a comprehensive review. Plast Reconstr Surg. 1989 Nov;84(5):827-37. doi: 10.1097/00006534-198911000-00021. No abstract available.
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.
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.
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.
Fan D, Xia Q, Wu S, Ye S, Liu L, Wang W, Guo X, Liu Z. Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial. Trials. 2018 Mar 2;19(1):155. doi: 10.1186/s13063-018-2478-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REC REF 2020-086
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.