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Adipose Derived Stem CellsPhase 2NCT04391621

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

A Phase 2 study testing Autologous Adipose Derived stem cell transplantation and Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 in people with Adipose Derived Stem Cells and Keloid, run by Makerere University at 2 sites in Uganda.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Adipose Derived Stem Cells, Keloid
What is being tested?
Autologous Adipose Derived stem cell transplantation and Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUganda
Study dates
1 May 2021to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients with a single keloid of 1-2cm3 as these have the highest response to any treatment administered.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Ronald Mbiine, First contact

+256774338585

mbiineron@gmail.com

Moses Galukande, Second contact

+256 772 410 503

galukand@gmail.com

Uganda2 sites, 2 recruiting

  • Department of Surgery, Makerere University College of Health Sciences

    Kampala

    Ronald Mbiine, First, +256 774 33 8585, mbiineron@gmail.com

    Moses Galukande, Second, +256 772 410503, galukand@gmail.com

    Recruiting

  • Kiruddu National Referral Hospital

    Kampala

    Rose Alenyo, +256772608026, alenyom@yahoo.co.uk

    Edris Kalanzi, +256703310088, kalanziw15@gmail.com

    Recruiting

Other trials in Uganda

About this study

Official title: Efficacy of Autologous Adipose Derived Stromal Vascular Fraction in the Treatment of Keloids

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.

Read the 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.

Being tested
Autologous Adipose Derived stem cell transplantation, Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
Keywords
Keloids, Adipose stem cells, Stem cells, Scars
Medical subject headings
Keloid, Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Adipose Derived stem cell transplantationProcedure or surgery

    Also called Stromal vasular fraction infiltration

    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_#1Drug

    Triamcinolone Acetanoide 40mg/ml suspension will be diluted into 1ml of 0.5% lignocaine solution and infiltrated into the selected keloid.

Study groups in NCT04391621
Study groupRoleWhat they receive
Adipose Derived Stem Cell(ADSC) armExperimentalIn 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).
Receives: Procedure: Autologous Adipose Derived stem cell transplantation
Triamcinolone Acetanoide (TAC) armActive comparatorThis arm will receive a single dose Triamcinolone acetanoide infiltration into the keloid. This will be a single dose infiltration of 40mg/cubic centimetres.
Receives: Drug: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Keloid regression

    The Change in the volume of the keloid tissue in cubic centimetres.

    Measured: 3 months

Secondary outcomes (1)

  1. The Patient and Observer Scar Assessment Scale(POSAS)

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start1 May 2021
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group single centre randomised control pilot trial with a 1:1 ratio.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391621
Sponsor's protocol ID
REC REF 2020-086
Status last verified
Jun 2021
First submitted
8 Oct 2019
Last updated
18 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will share the IPD only on request.

Publications

  • 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.

    PubMed 11807470

  • 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.

    PubMed 19295939

  • 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.

    PubMed 2682703

  • 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.

    PubMed 29467010

  • 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.

    PubMed 29799555

  • 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.

    PubMed 28316259

  • 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.

    PubMed 29499740

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Adipose Derived stem cell transplantation and Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 in people with Adipose Derived Stem Cells and Keloid, run by Makerere University at 2 sites in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ronald Mbiine, First (+256774338585, mbiineron@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Keloid regression (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04391621, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.

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