PDF of Trial CTRI Website URL

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Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 02:29:47 GMT)

CTRI Number CTRI/2009/091/000641 [Registered on: 20/08/2009] - Last Modified On 23/07/2014 Post Graduate Thesis No Type of Trial Interventional Type of Study Stem Cell Therapy Study Design Single Arm Trial Public Title of Study A clinical trial to study the safety and efficacy of ReliNethra C-Au (Autologous Conjunctival epithelial cell graft) in patients with pterygium Scientific Title of A prospective open-label single-arm multi-centric clinical study to assess the safety and efficacy of Study ReliNethra C-Au (Autologous Conjunctival epithelial cell graft) in patients with pterygium Secondary IDs if Any Secondary ID Identifier RLS/Oph/2005/01, Version 03, Dated Protocol Number 04/02/2008 Details of Principal Details of Principal Investigator Investigator or overall Name Dr Chandra Viswanathan Trial Coordinator (multi-center study) Designation Senior. Vice President Affiliation Reliance Life Sciences Pvt. Ltd Address Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra,India Thane MAHARASHTRA 400701 India Phone 02240678352 Fax 02240678099 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Chandra Viswanathan Query) Designation Senior. Vice President Affiliation Reliance Life Sciences Pvt. Ltd. Address Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre, R-282, TTC Area of MIDC, Rabale Thane MAHARASHTRA 400701 India Phone 02240678352 Fax 02240678099 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name DrChandra Viswanathan Designation Senior Vice President Affiliation Reliance Life Sciences Pvt.Ltd Address Reliance Life Sciences Pvt. Ltd., Dhirubhai Ambani Life Sciences Centre, R-282, TTC Area of MIDC, Rabale Thane MAHARASHTRA 400701 India

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Phone 02240678352 Fax 02240678099 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Reliance Life Sciences Pvt. Ltd. R-282 TTc MIDc industrial area, Thane Belapur Road, Rabale Navi Mumbai 400701 Primary Sponsor Primary Sponsor Details Name Reliance Life Sciences Pvt Ltd Address Dhirubhai Ambani Life Sciences Centre, R-282, TTC Area of MIDC, Thane belapur road, Rabale, Navi Mumbai 400701 Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor Reliance Life Sciences Pvt Ltd Reliance Life Sciences Pvt. Ltd., R-282 TTC MIDC industrial area, Rabale, Navi Mumbai- 400701 Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Radhika Tandon All India Institute of Room no. 475, 4th 01126593145 Medical Sciences floor, Dept. of 01126588626 (AIIMS) Ophthalmology, Dr. R. [email protected] P. Centre, AIIMS, New m Delhi – 110029 New Delhi DELHI Dr Smitesh Shah Dr. Shahs Laser Eye Radha Krishna Sankul, 02512311084 Institute Opposite Holy Cross 02512316605 Hospital, Carnic Road, [email protected] Kalyan – 421301 om Thane MAHARASHTRA Dr Sanjay Shah KEM Hospital 489 Rasta Peth, Sardar 02025882526 Moodliar Road, Pune – 411011 [email protected] Pune o.in MAHARASHTRA Dr Suhas Haldipurkar Laxmi Eye Institute Uran Road, 02227454060 Panvel-410206 02227491199 Mumbai (Suburban) haldipurkars@laxmieye. MAHARASHTRA org Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Ethics Committee, Approved 19/05/2008 No AIIMS Ethics Committee, KEM Approved 28/04/2008 No Independent Ethics Approved 24/11/2008 Yes Committee, Ethics R Us, Mumbai Independent Ethics Approved 04/10/2008 Yes Committee, Ethics R Us, Mumbai Regulatory Clearance Status Date

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Status from DCGI Approved/Obtained 08/10/2007 Health Condition / Health Type Condition Problems Studied Patients Patients requiring surgical correction for diseased or damaged conjunctiva. Intervention / Type Name Details Comparator Agent Intervention ReliNethra C-Au (Autologous A monolayered conjunctival conjunctival epithelial cell graft) epithelial cell graft comprising of conjunctival epithelial cells cultured ex vivo on a 4 cm sq denuded human amniotic membrane. This is one time graft transplant on the diseased conjunctival surface. Comparator Agent Not Applicable Not Applicable Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details 1. Male or female patients of 18 years and above
2. Patients with damaged or diseased conjunctival surface requiring surgical correction of pterygium, symblepharon, chronic allergic conjunctivitis, toxic epidermal necrolysis, wide field excision of tumors, and/or chemical injuries (as confirmed by history, prior medical records and/or clinical examination) Exclusion Criteria Exclusion Criteria Details 1. History of significant hematological, hepatic, renal, cardiovascular, respiratory, neurological, endocrinal or allergic disease 2. Patient with documented HIV infection/AIDS 3. Patients with history of diabetes 4. Patients with any ocular surface abnormality in the other eye Method of Generating Not Applicable Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Primary objective will be to evaluate the efficacy day 1, day 7, day 14, day 30, day 90 and day of ReliNethra C-Au defined as restoration of 180 physiological and functional conjunctival epithelium. Secondary Outcome Outcome Timepoints To evaluate the safety of ReliNethraTMC-Au day 1, day 7, day 14, day 30, day 90 and day 180 Target Sample Size Total Sample Size=25 Sample Size from India=25 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 1 Date of First 04/08/2008 Enrollment (India) Date of First No Date Specified Enrollment (Global)

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Estimated Duration of Years=0 Trial Months=6 Days=0 Recruitment Status of Completed Trial (Global) Recruitment Status of Completed Trial (India) Publication Details No publications done Brief Summary Overall, The study demonstrated that ReliNethraTM C-Au (monolayered conjunctival epithelial stem cell graft cultured on denuded human amniotic membrane) was efficacious to restore. Anatomical and physiological functions of conjunctiva when transplanted in the defect caused by excision of damaged or diseased conjunctiva,ReliNethraTM C-Au facilitated functional and physiological restoration of conjunctiva, and there was no secondary infection and other complications reported in the study.Finally, study demonstrated that ReliNethraTM C-Au is safe, well tolerated and easy to transplant in the patients requiring surgical correction of diseased or damaged conjunctiva.

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