CompletedPhase 4

Efficacy and Safety of Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency

Italy70 participantsStarted 2015-10

Plain-language summary

The purpose of this trial is to confirm the efficacy of Holoclar at one year after the first treatment in patients suffering from moderate to severe LSCD (Limbal Stem Cell Deficiency) secondary to ocular burns. In case of failure of the treatment and upon clinical indication of the Principal Investigator, a second transplant with Holoclar will be offered if eligibility will be confirmed. The efficacy of two treatments with Holoclar at one year after the last treatment will be also evaluated. All patients will be followed-up for 12 months after each implant to determine the treatment efficacy by an Independent Assessor.

Who can participate

Age range2 Years

SexALL

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Inclusion criteria

✓. Written informed consent prior to any study-related procedures.
✓. Adult male and female patients (≥18 years old); Five Paediatric patients aged 2 to 17 years will be also enrolled for safety purposes only.
✓. LSCD secondary to unilateral or bilateral physical or chemical ocular burns, with at least 1-2 mm2 of undamaged limbus to harvest stem cells for expansion in culture. LSCD will be considered for inclusion in presence of superficial neo-vascularization invading at least two corneal quadrants with central corneal involvement (including corneal neo-vascularisation, corneal opacity or corneal dyschromia) according to the independent assessors;
✓. Stability of LSCD, defined by a duration of disease of at least 24 months at the time of the Screening Visit and presence of continuum epithelium as per fluorescein staining scored as none or trace.
✓. Presence of severe impairment in visual acuity defined by a score of 1/10th or below 20/200 at the Snellen chart (legal blindness) after best correction (i.e. Best Corrected Visual Acuity);
✓. Absence of other clinical contraindications to ACLSC transplantation based upon investigator's judgment;
✓. A cooperative attitude to follow up the study procedures (Caregivers in case of minors).

Exclusion criteria

What they're measuring

Success of transplantation

Timeframe: 12 months after transplantation

Trial details

NCT IDNCT02577861

SponsorHolostem s.r.l.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12

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