Clinical trial NCT04553159: Autologous Adipose Derived Stem Cells Transplantation in the Treatment of Keloids.
Official title: Autologous Adipose Derived Stem Cell Transplantation in the Treatment of Keloids. A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keloid
Autologus Adipose Derived Stem Cells
Feasibility
Safety
Keywords: Adipose derived stem cells
Keloids
Stromal vascular fraction
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: three months
measure: The procedure time in hours.
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Department of Surgery, Makerere University College of Health Sciences
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.