KeratopathyPhase 2HULPOFTNCT01808378
Stem Cells Treatment for Bilateral Limbic Associated Keratopathy (HULPOFT)
A Phase 2 study testing Expanded adipose-derived stem cells in people with Keratopathy, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratopathy
- What is being tested?
- Expanded adipose-derived stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Signed informed consent
- -Previously diagnosed bilateral limbic obstruction
- -Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- -Suffering chronic keratopathy accomplishing the following criteria:
- Confirmed limbic obstruction with an impression cytology
- Repeated usual treatment failure for this pathology
Who cannot join
- -Having suffered a neoplasia in the previous 5 years
- -Local anesthesia allergies
- -Patients having participate in any other study in the previous 90 days to the inclusion
- -Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
- -Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
- -Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study
Show all 9Show fewer
- -Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent
- -Patients who have suffering major surgery or severe trauma in the prior 6 months
- -Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Mariano García-Arranz, PhD, 0034 912071022, mgarciaa.hulp@salud.madrid.org
Ana Boto de los Bueis, MD
About this study
Official title: Phase IIa Clinical Trial to Study the Feasability and Security of the Expanded Autologous Stem Cells (ASC) From Lipoaspirate in the Bilateral Limbic Associated Keratopathy Treatment
Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy
Read the detailed description
Intralesional use by inject of adipose derived stem cells
- Conditions
- Keratopathy
- Being tested
- Expanded adipose-derived stem cells
- Keywords
- Bilateral limbic associated keratopathy, Expanded Adipose Derived Stem Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded adipose-derived stem cellsDrug
Also called ASC
Local injection of autologousadipose derived stem cells
| Study group | Role | What they receive |
|---|---|---|
| Autologous Stem Cells | Experimental | Autologous expanded adipose-derived stem cells Receives: Drug: Expanded adipose-derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy
Micro ocular Photography Visual acuity
Measured: 16 weeks
Secondary outcomes (2)
Quality of life assessment using the SF-12 Questionnaire
SF-12 questionnaire
Measured: 1, 4, 16, 24 weeks
Adverse events
Data collection
Measured: 1, 4, 16, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for KeratopathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Boto de los Bueis, MD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808378
- Sponsor's protocol ID
- HULPOFT-2010-01
- Other IDs
- 2010-024328-53
- Acronym
- HULPOFT
- Status last verified
- Sep 2012
- First submitted
- 4 Sep 2012
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nishida K. Tissue engineering of the cornea. Cornea. 2003 Oct;22(7 Suppl):S28-34. doi: 10.1097/00003226-200310001-00005.
PubMed 14703705Arntz Bustos A, Durán de la Colina JA. Anatomía funcional de la superficie ocular. En; Superficie Ocular. Ed S.E.O. 2004; 1-12
Schermer A, Galvin S, Sun TT. Differentiation-related expression of a major 64K corneal keratin in vivo and in culture suggests limbal location of corneal epithelial stem cells. J Cell Biol. 1986 Jul;103(1):49-62. doi: 10.1083/jcb.103.1.49.
PubMed 2424919Tseng SC. Staging of conjunctival squamous metaplasia by impression cytology. Ophthalmology. 1985 Jun;92(6):728-33. doi: 10.1016/s0161-6420(85)33967-2.
PubMed 3897935Kenyon KR, Tseng SC. Limbal autograft transplantation for ocular surface disorders. Ophthalmology. 1989 May;96(5):709-22; discussion 722-3. doi: 10.1016/s0161-6420(89)32833-8.
PubMed 2748125Santos MS, Gomes JA, Hofling-Lima AL, Rizzo LV, Romano AC, Belfort R Jr. Survival analysis of conjunctival limbal grafts and amniotic membrane transplantation in eyes with total limbal stem cell deficiency. Am J Ophthalmol. 2005 Aug;140(2):223-30. doi: 10.1016/j.ajo.2005.03.022.
PubMed 16023069Chen JJ, Tseng SC. Corneal epithelial wound healing in partial limbal deficiency. Invest Ophthalmol Vis Sci. 1990 Jul;31(7):1301-14.
PubMed 1694836Tan DT, Ficker LA, Buckley RJ. Limbal transplantation. Ophthalmology. 1996 Jan;103(1):29-36. doi: 10.1016/s0161-6420(96)30737-9.
PubMed 8628556Samson CM, Nduaguba C, Baltatzis S, Foster CS. Limbal stem cell transplantation in chronic inflammatory eye disease. Ophthalmology. 2002 May;109(5):862-8. doi: 10.1016/s0161-6420(02)00994-6.
PubMed 11986089Tsubota K, Toda I, Saito H, Shinozaki N, Shimazaki J. Reconstruction of the corneal epithelium by limbal allograft transplantation for severe ocular surface disorders. Ophthalmology. 1995 Oct;102(10):1486-96. doi: 10.1016/s0161-6420(95)30841-x.
PubMed 9097796Ilari L, Daya SM. Long-term outcomes of keratolimbal allograft for the treatment of severe ocular surface disorders. Ophthalmology. 2002 Jul;109(7):1278-84. doi: 10.1016/s0161-6420(02)01081-3.
PubMed 12093650Pellegrini G, De Luca M, Arsenijevic Y. Towards therapeutic application of ocular stem cells. Semin Cell Dev Biol. 2007 Dec;18(6):805-18. doi: 10.1016/j.semcdb.2007.09.011. Epub 2007 Sep 16.
PubMed 17959397Inatomi T, Nakamura T, Koizumi N, Sotozono C, Yokoi N, Kinoshita S. Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelial transplantation. Am J Ophthalmol. 2006 Feb;141(2):267-275. doi: 10.1016/j.ajo.2005.09.003.
PubMed 16458679Yao YF, Inoue Y, Miyazaki D, Shimomura Y, Ohashi Y, Tano Y. Ocular resurfacing and alloepithelial rejection in a murine keratoepithelioplasty model. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2623-33.
PubMed 7499085Daya SM, Watson A, Sharpe JR, Giledi O, Rowe A, Martin R, James SE. Outcomes and DNA analysis of ex vivo expanded stem cell allograft for ocular surface reconstruction. Ophthalmology. 2005 Mar;112(3):470-7. doi: 10.1016/j.ophtha.2004.09.023.
PubMed 15745776
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Clinical Trial to Study the Feasability and Security of the Expanded Autologous Stem Cells (ASC) From Lipoaspirate in the Bilateral Limbic Associated Keratopathy Treatment
- ClinicalTrials.gov ID
- NCT01808378
- Acronym / sponsor ID
- HULPOFT / HULPOFT-2010-01
- Conditions
- Keratopathy
- Keywords
- Bilateral limbic associated keratopathy, Expanded Adipose Derived Stem Cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 11 Mar 2013 (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.
Evaluate the use of the autologous ASC for the treatment of bilateral limbic associated keratopathy
Detailed description
Intralesional use by inject of adipose derived stem cells
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Stem Cells | Experimental | Drug: Expanded adipose-derived stem cellsAutologous expanded adipose-derived stem cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- -Signed informed consent
- -Previously diagnosed bilateral limbic obstruction
- -Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
- -Suffering chronic keratopathy accomplishing the following criteria:
Key exclusion criteria (9 listed)
- -Having suffered a neoplasia in the previous 5 years
- -Local anesthesia allergies
- -Patients having participate in any other study in the previous 90 days to the inclusion
- -Patients on medication with tacrolimus or cyclosporine in the 4 previous week to the cellular therapy
- -Any medical or psychiatric illness that, in the investigator opinion, could suppose a reason for the study exclusion
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 |
|---|---|---|
| Expanded adipose-derived stem cellsAlso: ASCLocal injection of autologousadipose derived stem cells | Drug | Autologous Stem Cells |
Primary outcome
Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy
Time frame: 16 weeks
Micro ocular Photography Visual acuity
2 secondary outcomes
Quality of life assessment using the SF-12 Questionnaire
Time frame: 1, 4, 16, 24 weeks
Adverse events
Time frame: 1, 4, 16, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
- Background: PubMed 14703705Nishida K. Tissue engineering of the cornea. Cornea. 2003 Oct;22(7 Suppl):S28-34. doi: 10.1097/00003226-200310001-00005.
- BackgroundArntz Bustos A, Durán de la Colina JA. Anatomía funcional de la superficie ocular. En; Superficie Ocular. Ed S.E.O. 2004; 1-12
- Background: PubMed 2424919Schermer A, Galvin S, Sun TT. Differentiation-related expression of a major 64K corneal keratin in vivo and in culture suggests limbal location of corneal epithelial stem cells. J Cell Biol. 1986 Jul;103(1):49-62. doi: 10.1083/jcb.103.1.49.
- Background: PubMed 3897935Tseng SC. Staging of conjunctival squamous metaplasia by impression cytology. Ophthalmology. 1985 Jun;92(6):728-33. doi: 10.1016/s0161-6420(85)33967-2.
- Background: PubMed 2748125Kenyon KR, Tseng SC. Limbal autograft transplantation for ocular surface disorders. Ophthalmology. 1989 May;96(5):709-22; discussion 722-3. doi: 10.1016/s0161-6420(89)32833-8.
- Background: PubMed 16023069Santos MS, Gomes JA, Hofling-Lima AL, Rizzo LV, Romano AC, Belfort R Jr. Survival analysis of conjunctival limbal grafts and amniotic membrane transplantation in eyes with total limbal stem cell deficiency. Am J Ophthalmol. 2005 Aug;140(2):223-30. doi: 10.1016/j.ajo.2005.03.022.
- Background: PubMed 1694836Chen JJ, Tseng SC. Corneal epithelial wound healing in partial limbal deficiency. Invest Ophthalmol Vis Sci. 1990 Jul;31(7):1301-14.
- Background: PubMed 8628556Tan DT, Ficker LA, Buckley RJ. Limbal transplantation. Ophthalmology. 1996 Jan;103(1):29-36. doi: 10.1016/s0161-6420(96)30737-9.
- Background: PubMed 11986089Samson CM, Nduaguba C, Baltatzis S, Foster CS. Limbal stem cell transplantation in chronic inflammatory eye disease. Ophthalmology. 2002 May;109(5):862-8. doi: 10.1016/s0161-6420(02)00994-6.
- Background: PubMed 9097796Tsubota K, Toda I, Saito H, Shinozaki N, Shimazaki J. Reconstruction of the corneal epithelium by limbal allograft transplantation for severe ocular surface disorders. Ophthalmology. 1995 Oct;102(10):1486-96. doi: 10.1016/s0161-6420(95)30841-x.
- Background: PubMed 12093650Ilari L, Daya SM. Long-term outcomes of keratolimbal allograft for the treatment of severe ocular surface disorders. Ophthalmology. 2002 Jul;109(7):1278-84. doi: 10.1016/s0161-6420(02)01081-3.
- Background: PubMed 17959397Pellegrini G, De Luca M, Arsenijevic Y. Towards therapeutic application of ocular stem cells. Semin Cell Dev Biol. 2007 Dec;18(6):805-18. doi: 10.1016/j.semcdb.2007.09.011. Epub 2007 Sep 16.
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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.
Ana Boto de los Bueis, MD principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Expanded adipose-derived stem cells in people with Keratopathy, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 6 inclusion and 9 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 11 Mar 2013. 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 Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mariano García-Arranz, PhD (0034 912071022, mgarciaa.hulp@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the practicability and security of the autologous expanded lipoaspirated stem cells for the treatment of bilateral limbic associated keratopathy (time frame: 16 weeks). 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 NCT01808378, which also lists 24 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 11 Mar 2013.