Phase 2A Multicenter Clinical Trial To Determine The Feasibility And Safety Of The Use Of Adipose-Derived Mesenchymal Stem Cells (Asc( In The Treatment Of Patients With Cicatricial Conjunctivitis

Published 2025 - 43rd Congress of the ESCRS

Reference: FP27.13 | Type: Free paper | DOI: 10.82333/9x42-c310

Authors: Rajendra Prasad Prasad* ¹

¹EYE,RP EYE INSTITUTE,New Delhi ,India

Purpose

To conduct a Phase IIa clinical trial to evaluate the safety of subconjunctival injection for active cicatricial conjunctivitis associated with Lyell’s syndrome, Stevens-Johnson syndrome, and mucous membrane pemphigoid.

Setting

Multicenter clinical trial in tertiary care centers

Methods

Prospective multicenter clinical IIa trial in patients with active inflammation due to Lyell’s syndrome, Stevens-Johnson syndrome, and mucous membrane pemphigoid

I-IIc IIIb.

The fiirst 10 patients received a subconjunctival inyection of adipose derived mesenchymal stem cells. The following 10 patients received two injections 2 weeks apart.

The cellular therapy was added to the standar treatment.

patients were followed during 6 months

Results

20 patients (9 men 11 women) were recruited. There were no follow-up losses. 11 patients had ocular pemphigoid, 3 had Lyell´s syndrome and 8 Stevens-Johnson syndrome.

One patient showed a limited simblefaron at one of the injection sights, two patients presented short term hyperemia, there were other seven mild adverse reaction describe none related with the therapy.

OSDI questionnaire improved globally at 1, 3 months in a statistically significant way, this improvement was mantained without signification at 6 months

There was a promising trend towards improvement in the conjunctival inflammation score

Conclusions

•Allogenic mesenchymal adipose derived stem cells injection seems safe and feasible in the treatment of patients with mild/moderate MMP and SJS

•Allogenic mesenchymal adipose derived stem cells may be a useful tool to improve symptoms and inflammation in mild/moderate cases of MMP and SJS

•Phase IIb and III randomized controlled trials are needed