MSCs: Dermogenesis With Mesenchymal Stem Cells

• Sponsor: King Edward Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06135519
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

Dermogenesis With Mesenchymal Stem Cells in treating Post Acne Depressed Spots

Condition or Disease	Intervention/Treatment	Phase
Dermal Regeneration	Procedure: Autologous Mesenchymal stem cells injection; Procedure: Homogenized fat injection	N/A

Detailed Description

management at two different stages of the course of the disease. First one at the stage of active disease which needs cleansers, antibiotics, retinoids, anti inflammatory agents and hormonal manipulation. Once active disease is over, patients report to clinician with depressed spots which are caused by localized dermal disruption and fat atrophy post inflammation or spontaneous epithelial rupture or scratching by the patient. These acne spots are hard to treat due to many reasons. Firstly, excision is difficult as size of most of them is small and they are in a large in number. Secondly, filling with and without subcision is not adequately addressing the deformity. Currently, a combination of filling with synthetic filler or fat and resurfacing by peeling, LASER or dermabrasion is in practice. In-spite of all, a treatment is still required to address post acne spots (Ice Spec Spots) adequately.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group A with MSCs Group B with FatGroup A with MSCs Group B with Fat
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dermogenesis With Mesenchymal Stem Cells: A Fabulous Remedy For Post Acne Depressed Spots
• Actual Study Start Date: Jul 23, 2023
• Anticipated Primary Completion Date: Jan 22, 2024
• Anticipated Study Completion Date: Jan 22, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mesenchymal stem cells Mesenchymal Stem Cells taken from adipose tissue will be used	Procedure: Autologous Mesenchymal stem cells injection; Autologous Mesenchymal stem cells will be seperated from harvested fat and injected in acne scars
Experimental: Homogenized fat Adipose tissue will be harvested and used	Procedure: Homogenized fat injection; Autologous fat will be harvested, homogenized and injected.

Outcome Measures

Primary Outcome Measures

1. Dermal thickness [3 months]

   on microscopy of biopsy section

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Acne spots

Exclusion Criteria:

• Active acne

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	King Edward Medical University	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

• King Edward Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Afzaal Bajwa, Assistant Professor, King Edward Medical University
• ClinicalTrials.gov Identifier: NCT06135519
• Other Study ID Numbers: kemu/23/2
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 21, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 21, 2023