Autologous Cellular Graft in Surgical Treatment of Vitiligo

NCT05503368 | Suspended DMC

• 1 other identifier: VS-8822
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a double blinded self controlled randomized trial to assess Autologous Micro Cellular Grafts in surgical treatment of stable resistant vitiligo. Given the stem cells, progenitor cells, and growth factors rich hair follicle based suspension resulting from Autologous Cellular Micro grafts (ACM), we aim at assessing the efficacy of ACM generated suspension in comparison to follicle cell suspension in surgical treatment of stable resistant vitiligo.

Conditions

Vitiligo, Generalized

Keywords

stable resistant vitiligo; follicular cell suspension; Autologous cellular Micro-grafts; non cultured epidermal suspension

Outcome Measures

Primary Outcomes (1)

• comparing change in surface area in three arms

  Percent change in surface area calculated by point counting technique will be compared between three arms

  3 months follow up are required to assess response

Secondary Outcomes (1)

• comparing percent of repigmentation in three arms

  3 months follow up are required to assess response

Study Arms (3)

Autologous Cellular Micro-grafts suspension added to non cultured epidermal suspension (NCES)

EXPERIMENTAL

Under local anesthesia, a 2.5 mm punch biopsy will be used to extract 3 scalp tissue specimens from the patient's occiput behind the ear, using Rigeneracons medical device (CE certified class I; Human Brain Wave, Turin, Italy). The collected specimens will be placed in Rigeneracons by adding 1.5 mL of sterile physiologic solution to the device. The device then generates a cellular suspension by rotation of Rigeneracons at 80 RPM for 2 minutes. Subsequently, the obtained suspension is diluted with an additional 3 mL sterile physiologic solution. The resulting suspension will be added to NCES and placed on one of the derma braded vitiligo patches

Procedure: surgical treatment of vitiligo using NCES

Follicle cell suspension added t NCES

ACTIVE COMPARATOR

• Under local anesthesia, 1 mm punch will be used to extract hair-follicles from occipital scalp behind the ear. Depending on the area to be transplanted, one hair follicle will be etracted for each 1 cm2. The extracted hair-follicles are washed with phosphate buffered saline (PBS) for about 3 times. The hair-follicles are then incubated with 0.25% trypsin - 0.05% ethylene diamine tetra acetic acid (EDTA) at 37°C for 90 min to prepare the single cell suspension. Within 15-20 min of incubation, the cells start loosening from each other. The hair-follicles are subsequently placed in another tube of trypsin and EDTA. At the end of three such cycles, a thin keratinous shaft is left behind. The cell suspensions of all the tubes are added in a single tube. The final cell pellet is obtained by centrifuging the combined cell suspension at 1000 rpm for 5 min. The resulting suspension will be added to NCES and placed on a comparable derma braded lesion

Procedure: surgical treatment of vitiligo using NCES

Non cultured epidermal suspension (NCES)

ACTIVE COMPARATOR

Melanocyte keratinocyte pellet will be prepared. Donor skin will be harvested from the gluteal region ; using a sterile shaving blade mounted on a Kocher's forceps. Cell Suspension will be prepared by placing the donor skin in 0.25% trypsin-EDTA (GIBCO) solution for 40 minutes at 37 ᴼC. sample and trypsin will be poured into a labelled petri dishes then neutralized using ringer's lactate. All the steps will be performed in a laminar air flow bench under strict aseptic conditions. The epidermis will be detached from the dermis which will be discarded. Then the epidermis will be cut into tiny pieces and scrapped so that no pigment is left on the surface. Afterwards, they will be transferred to sterile falcon tubes and centrifuged for 10 minutes at 1,000 rpm. The floating epidermal fragments and supernatant fluid will be removed, leaving the cell pellet containing epidermal cells rich in melanocytes and Keratinocytes at the bottom.

Procedure: surgical treatment of vitiligo using NCES

Interventions

surgical treatment of vitiligo using NCES PROCEDURE

NCES is the standard technique for surgical treatment of vitiligo, herein we compare the standard technique, to added autologous cellular micro-grafts and to follicle cell suspension

Autologous Cellular Micro-grafts suspension added to non cultured epidermal suspension (NCES); Follicle cell suspension added t NCES; Non cultured epidermal suspension (NCES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-segmental vitiligo (NSV) / segmental resistant lesions; with either 2 comparable lesions or large patches that can be divided
• Stability for ≥ 1 year
• Age \>18 years
• Lack of treatment for at least 1 month prior to surgery.

You may not qualify if:

• Vitiligo lesions responsive to conventional treatment modalities
• Active vitiligo; new lesions, expansion of old lesions or koebnerization in \< 1 year
• Age \< 18 years.
• Keloidal tendency
• Bleeding tendency
• Pregnant females.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospitals, dermatology outpatient clinic

Cairo, Egypt

Location

Related Publications (7)

• El-Zawahry BM, Esmat S, Bassiouny D, Zaki NS, Sobhi R, Saleh MA, Abdel-Halim D, Hegazy R, Gawdat H, Samir N, El-Hawary M, El Maadawi Z, Gouda H, Khorshied M. Effect of Procedural-Related Variables on Melanocyte-Keratinocyte Suspension Transplantation in Nonsegmental Stable Vitiligo: A Clinical and Immunocytochemical Study. Dermatol Surg. 2017 Feb;43(2):226-235. doi: 10.1097/DSS.0000000000000962.

  PMID: 28157763 RESULT

• Ruiz RG, Rosell JMC, Ceccarelli G, De Sio C, De Angelis GC, Pinto H, Astarita C, Graziano A. Progenitor-cell-enriched micrografts as a novel option for the management of androgenetic alopecia. J Cell Physiol. 2020 May;235(5):4587-4593. doi: 10.1002/jcp.29335. Epub 2019 Oct 23.

  PMID: 31643084 RESULT

• Zari S. Short-Term Efficacy of Autologous Cellular Micrografts in Male and Female Androgenetic Alopecia: A Retrospective Cohort Study. Clin Cosmet Investig Dermatol. 2021 Nov 19;14:1725-1736. doi: 10.2147/CCID.S334807. eCollection 2021.

  PMID: 34824538 RESULT

• Razmi T M, Kumar R, Rani S, Kumaran SM, Tanwar S, Parsad D. Combination of Follicular and Epidermal Cell Suspension as a Novel Surgical Approach in Difficult-to-Treat Vitiligo: A Randomized Clinical Trial. JAMA Dermatol. 2018 Mar 1;154(3):301-308. doi: 10.1001/jamadermatol.2017.5795.

  PMID: 29387874 RESULT

• Thakur V, Kumar S, Kumaran MS, Kaushik H, Srivastava N, Parsad D. Efficacy of Transplantation of Combination of Noncultured Dermal and Epidermal Cell Suspension vs Epidermal Cell Suspension Alone in Vitiligo: A Randomized Clinical Trial. JAMA Dermatol. 2019 Feb 1;155(2):204-210. doi: 10.1001/jamadermatol.2018.4919.

  PMID: 30601885 RESULT

• Mohanty S, Kumar A, Dhawan J, Sreenivas V, Gupta S. Noncultured extracted hair follicle outer root sheath cell suspension for transplantation in vitiligo. Br J Dermatol. 2011 Jun;164(6):1241-6. doi: 10.1111/j.1365-2133.2011.10234.x.

  PMID: 21275943 RESULT

• Gho CG, Braun JE, Tilli CM, Neumann HA, Ramaekers FC. Human follicular stem cells: their presence in plucked hair and follicular cell culture. Br J Dermatol. 2004 May;150(5):860-8. doi: 10.1111/j.1365-2133.2004.05862.x.

  PMID: 15149497 RESULT

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rania M Mogawer

  Kasr Alainy, Cairo University Hospitals

  PRINCIPAL INVESTIGATOR

• Samia M Esmat

  Kasr Alainy, Cairo University Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator doing the procedure is the only one who will know which side is assigned to which procedure, but the rest of the investigators including the ones assessing the outcome will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: self controlled study where 3 comparable lesions will be selected in each patient

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: August 16, 2022
• Study Start: June 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: April 1, 2024
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 12 months after article publication
• Access Criteria: Controlled Access: Researchers who provide a methodologically sound proposal will be allowed to access data to achieve aims in the approved proposal.

Locations

EG (1)