Corneal InjuriesPhase 1ExCellNCT02948023
Stem Cells Therapy for Corneal Blindness
A Phase 1 study testing Ex-vivo cultivated limbal stem cell pool in people with Corneal Injuries and Corneal Burns, run by L.V. Prasad Eye Institute at 1 site in India.
Trial summary
This is a investigative initiated, comparative pilot clinical trial to ascertain the safety of application of ex-vivo cultivated limbal stem cells in human eyes for treating different superficial corneal pathologies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Corneal Injuries, Corneal Burns, Corneal Scars and Opacities
- What is being tested?
- Ex-vivo cultivated limbal stem cell pool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 31 Aug 2016to Aug 2019
- Phase
- Phase 1
- 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
- Male and Female participants who are aged between 18-60 years.
- Patients who are having with unilateral blindness due to superficial (defined as involving the anterior 200 microns of the corneal stroma on ASOCT imaging) corneal wounds, ulcers, burns and scars.
- Eyes with otherwise normal.
Who cannot join
- Active infection, proven by microbiology.
- Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation.
- Children (<18 years of age).
- Inability/refusal to give written informed consent or to undergo any of the anterior segment imaging tests.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
LV Prasad Eye Institute
Hyderabad, Telangana, 500034
Sayan Basu, MBBS, MS, +9140 3061 2625 ext. 2625, sayanbasu@lvpei.org
Vivek Singh Singh, MSc PhD, +9140 3061 2286 ext. 2286, viveksingh@lvpei.org
About this study
Official title: Ex-vivo Cultivated Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies
This is a investigative initiated, comparative pilot clinical trial to ascertain the safety of application of ex-vivo cultivated limbal stem cells in human eyes for treating different superficial corneal pathologies. Pre-clinical work in murine models have already demonstrated efficacy of this technique in curing murine corneal pathologies.
Read the detailed description
In this prospective interventional study patients with superficial corneal pathologies like scars, ulcers and burns will undergo a surgical procedure. Limbal ring from a cadaveric donor tissue, which is therapeutically accepted and serologically tested, is collected. This tissue will then be cultivated in the stem cell biology laboratory using standardized culture technique. Briefly the limbal tissue will be cut up into small pieces and digested overnight using an enzyme (Collagenase L). The cells obtained from the digest will be cultured on a petri-dish using 2% serum and growth factors. The cultured cells will be passaged three times to remove all epithelial cells from the culture. In the second procedure, the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 5x10^3 cells/uL diluted in the thrombin component of fibrin glue (TISEEL, Baxter) will be applied to the debrided corneal stroma. A soft bandage contact lens will be placed over the cornea at the end of the procedure. The patient will receive topical antibiotic and steroid eye drops in the post-operative period. Periodic comprehensive ophthalmic evaluation along with anterior segment optical coherence tomography (ASOCT) scanning and slit-lamp photography will be done at day 1, day 7, day 45 and day 90.
- Conditions
- Corneal Injuries, Corneal Burns, Corneal Scars and Opacities
- Being tested
- Ex-vivo cultivated limbal stem cell pool
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex-vivo cultivated limbal stem cell poolBiological
0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.
| Study group | Role | What they receive |
|---|---|---|
| Standard Surgical therapy | No intervention | Includes the control group that fulfills the inclusion criteria |
| Ex-vivo cultivated limbal stem cell pool | Active comparator | 0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement. Receives: Biological: Ex-vivo cultivated limbal stem cell pool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular or systemic adverse effects
Measured: until 3months after surgery
Secondary outcomes (1)
Visual improvement after treatment.
Checking for the improvement in visual acuity that will be calculated using LogMAR chart (where 20/20 vision is normal).
Measured: until 3months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start31 Aug 2016
- Primary completionFeb 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corneal InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L.V. Prasad Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivek Singh, L.V. Prasad Eye Institute
- Investigators
- Sayan Basu, MBBS, MS, Principal investigator, LV Prasad Eye InstitiuteVivek Singh, MSc PhD, Principal investigator, LV Prasad Eye Institiute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948023
- Sponsor's protocol ID
- LVPEI-2014-1 Version 1 15Jan14
- Acronym
- ExCell
- Status last verified
- Mar 2018
- First submitted
- 20 Oct 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Basu S, Hertsenberg AJ, Funderburgh ML, Burrow MK, Mann MM, Du Y, Lathrop KL, Syed-Picard FN, Adams SM, Birk DE, Funderburgh JL. Human limbal biopsy-derived stromal stem cells prevent corneal scarring. Sci Transl Med. 2014 Dec 10;6(266):266ra172. doi: 10.1126/scitranslmed.3009644.
PubMed 25504883Basu S, Damala M, Singh V. Limbal Stromal Stem Cell Therapy for Acute and Chronic Superficial Corneal Pathologies: Early Clinical Outcomes of The Funderburgh Technique. Investigative Ophthalmology & Visual Science. 2017 Jun 23;58(8):3371-337
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex-vivo Cultivated Limbal Stem Cell Transplantation for Treatment of Superficial Corneal Pathologies
- ClinicalTrials.gov ID
- NCT02948023
- Acronym / sponsor ID
- ExCell / LVPEI-2014-1 Version 1 15Jan14
- Conditions
- Corneal Injuries, Corneal Burns, Corneal Scars and Opacities
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- L.V. Prasad Eye InstituteUniversity, hospital or other
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a investigative initiated, comparative pilot clinical trial to ascertain the safety of application of ex-vivo cultivated limbal stem cells in human eyes for treating different superficial corneal pathologies. Pre-clinical work in murine models have already demonstrated efficacy of this technique in curing murine corneal pathologies.
Detailed description
In this prospective interventional study patients with superficial corneal pathologies like scars, ulcers and burns will undergo a surgical procedure. Limbal ring from a cadaveric donor tissue, which is therapeutically accepted and serologically tested, is collected. This tissue will then be cultivated in the stem cell biology laboratory using standardized culture technique. Briefly the limbal tissue will be cut up into small pieces and digested overnight using an enzyme (Collagenase L). The cells obtained from the digest will be cultured on a petri-dish using 2% serum and growth factors. The cultured cells will be passaged three times to remove all epithelial cells from the culture. In the second procedure, the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 5x10^3 cells/uL diluted in the thrombin component of fibrin glue (TISEEL, Baxter) will be applied to the debrided corneal stroma. A soft bandage contact lens will be placed over the cornea at the end of the procedure. The patient will receive topical antibiotic and steroid eye drops in the post-operative period. Periodic comprehensive ophthalmic evaluation along with anterior segment optical coherence tomography (ASOCT) scanning and slit-lamp photography will be done at day 1, day 7, day 45 and day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Surgical therapy | No intervention | –Includes the control group that fulfills the inclusion criteria |
| Ex-vivo cultivated limbal stem cell pool | Active comparator | Biological: Ex-vivo cultivated limbal stem cell pool0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and Female participants who are aged between 18-60 years.
- Patients who are having with unilateral blindness due to superficial (defined as involving the anterior 200 microns of the corneal stroma on ASOCT imaging) corneal wounds, ulcers, burns and scars.
- Eyes with otherwise normal.
Key exclusion criteria (4 listed)
- Active infection, proven by microbiology.
- Unknown etiology, post-herpetic eye disease or eyes with active intra-ocular inflammation.
- Children (<18 years of age).
- Inability/refusal to give written informed consent or to undergo any of the anterior segment imaging tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ex-vivo cultivated limbal stem cell pool0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement. | Biological | Ex-vivo cultivated limbal stem cell pool |
Primary outcome
Ocular or systemic adverse effects
Time frame: until 3months after surgery
1 secondary outcome
Visual improvement after treatment.
Time frame: until 3months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Results publication: PubMed 25504883Basu S, Hertsenberg AJ, Funderburgh ML, Burrow MK, Mann MM, Du Y, Lathrop KL, Syed-Picard FN, Adams SM, Birk DE, Funderburgh JL. Human limbal biopsy-derived stromal stem cells prevent corneal scarring. Sci Transl Med. 2014 Dec 10;6(266):266ra172. doi: 10.1126/scitranslmed.3009644.
- Results publicationBasu S, Damala M, Singh V. Limbal Stromal Stem Cell Therapy for Acute and Chronic Superficial Corneal Pathologies: Early Clinical Outcomes of The Funderburgh Technique. Investigative Ophthalmology & Visual Science. 2017 Jun 23;58(8):3371-337
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayan Basu, MBBS, MS principal investigator
LV Prasad Eye Institiute
Vivek Singh, MSc PhD principal investigator
LV Prasad Eye Institiute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ex-vivo cultivated limbal stem cell pool in people with Corneal Injuries and Corneal Burns, run by L.V. Prasad Eye Institute at 1 site in India.
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 3 inclusion and 4 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 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Sayan Basu, MBBS, MS (9140-30612625 ext. 2625, sayanbasu@lvpei.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular or systemic adverse effects (time frame: until 3months after surgery). 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 NCT02948023, which also lists 2 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 6 Mar 2018.