Retinitis Pigmentosa (RP)Phase 2NCT04763369
Investigation of Therapeutic Efficacy and Safety of UMSCs for the Management of Retinitis Pigmentosa (RP)
A Phase 2 study testing Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa and Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa in people with Retinitis Pigmentosa (RP), run by Jinnah Burn and Reconstructive Surgery Centre, Lahore at 1 site in Pakistan.
Trial summary
Retinitis pigmentosa (RP) is the most common hereditary retinal disorder (accounts for 20% of children attending blind schools in Pakistan) which causes degeneration of rod and cone photoreceptors. Rods and cones largely depend on the retinal pigment epithelium for their proper functioning. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Retinitis Pigmentosa (RP)
- What is being tested?
- Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa and Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2021to Jun 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will be voluntarily participated for UMSCs injection for the treatment of RP.
- Patients who will be able to adhere to the study follow-up and protocol requirements.
- Individuals with age ranges from 18 years to 70 years will be included.
- Patients with best corrected visual acuity (BCVA) from 50 letters to 110 letters or <20/50 in the ETDRS chart testing (Topcon CC-100 XP, Japan).
- Mean deviation values ranging between -33.0 and - 5.0 dB with compass visual field analysis (threshold 24-2, Sita Standard, Stimulus 3-white).
- Diagnosis of any phenotypic or genotypic variation of RP, confirmed by clinical history, fundus appearance, visual field, electroretinogram and genetic mutation analysis.
Who cannot join
- Presence of cataracts or other media opacity that might affect the visual field, mean deviation, or electroretinogram recordings.
- Presence of another ocular disease except RP (i.e., uveitis, strabismus, glaucoma) that causes visual field and optic disc changes.
- Presence of any systemic disorder that may affect visual functions. This includes diabetes, neurological disorders, and uncontrolled systemic hypertension.
- Smokers will be excluded from the study.
- Individuals who underwent ocular surgery except cataract extraction will be considered as excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Stem Cell laboratory, Jinnah Burn & Reconstructive Surgery Centre
Lahore, Punjab Province, 54550
Muhammad Ali, PhD, +923218429448, riazuddin@aimrc.org
About this study
Official title: Investigation of Therapeutic Efficacy and Safety of Umbilical Cord Derived Mesenchymal Stem Cells (UMSCs) for the Management of Retinitis Pigmentosa (RP)
Retinitis pigmentosa (RP) is the most common hereditary retinal disorder (accounts for 20% of children attending blind schools in Pakistan) which causes degeneration of rod and cone photoreceptors. Rods and cones largely depend on the retinal pigment epithelium for their proper functioning. Various growth factors and their receptors are present in retinal epithelium and a number of genes are responsible for the production of these growth factors. Genetic mutation in any of these genes causes retinal degeneration by progressive loss of retinal pigment epithelium and photoreceptors. The disease initially starts with night blindness and leads to the loss of central vision and eventually total blindness. To date, there is no definitive cure for patients suffering from RP. Recently, stem cell based therapies have shown great promise for the management of RP. It is well documented that umbilical cord derived mesenchymal stem cells (UMSCs) have the ability to release various paracrine and immunomodulatory factors that are similar to those synthesized by retinal pigment epithelium. Multiple routes including systemic (intravenous) and localized (subretinal, intravitreal, suprachoroidal and sub-tenon) have been employed to administer UMSCs for the management of RP. It is important to note that deep sub-tenon region (space between the sclera and the conjunctiva) acts as both natural culture medium for cells and as immune privileged site because of avascularity of the region. It has been reported that the injection of UMSCs in sub-tenon space of human subjects have improved the visual acuity even after 1 year post-injection. In addition, the injection of UMSCs in suprachoroidal space enhances the entry of growth factors released by the cells into choroidal flow and maintain the constant growth factors secretion to the choroidal and retinal tissues. Limoli and colleagues were the first to report the suprachoroidal administration of cells being the safe mode of cell delivery with no complications. The present study is aimed to investigate the safety and therapeutic efficacy of UMSC injection employing two different routes (sub-tenon injection versus suprachoroidal injection) for the treatment of RP in human subjects.
Read the detailed description
Isolation and characterization of human umbilical cord derived mesenchymal stem cells (UMSCs): The culturing and characterization of UMSCs will be performed as documented by Ali and colleagues. Briefly, human umbilical cord tissues along with informed consent forms will be collected from COVID-19- and hepatitis B, C virus-negative women with healthy pregnancies during the Cesarean Section surgery after completion of gestation period. The umbilical cord tissue will be transported in sterile 1x phosphate-buffered saline (PBS) containing penicillin and streptomycin on ice. In the biosafety cabinet, the cord will be washed with 4-5 changes of sterile 1x PBS and placed in a Petri plate with 15ml PBS. The cord will then gently scrap with a surgical blade to remove any dead cells. A 9 cm umbilical cord will be cut into three equal pieces and wash thoroughly to remove blood clots, umbilical cord arteries, and veins. Segments will be washed three times with PBS and minced. The minced pieces will be incubated in 17.5ml of collagenase solution (201 U/ml collagenase type I in serum-free DMEM-HG) in a 50ml conical tube for ~3 hrs in an incubator at 5% CO2, 95% humidity at 37oC. After ~3 hrs, the digested lysate will be passed through strainer and will be diluted three times with 1x PBS. Following centrifugation, the cells will be seeded into two T-25cm2 flasks and will be placed in an incubator at 5% CO2, 95% humidity at 37o C. The flasks will be fed with fresh media (DMEM-HG supplemented with 20% FBS and 1% antibiotic solution) every third day. At around day 18, cells will reach up to 85% confluency and will be transferred in two T-75cm2 flasks with media replaced at alternate days. UMSCs at P3 will be characterized using different specific antibodies. Cells at P3 will be employed for injection in RP patients.
- Conditions
- Retinitis Pigmentosa (RP)
- Being tested
- Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa, Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa
- Keywords
- Retinitis pigmentosa, Stem cells treatment
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosaBiological
Cultured stem cells will be injected in the sub-tenon space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360.
Injection of stem cells in suprachoroidal space of eye for the management of Retinitis PigmentosaBiological
Cultured stem cells will be injected in the suprachoroidal space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360.
| Study group | Role | What they receive |
|---|---|---|
| Sub-tenon injection group | Experimental | In total twenty five subjects will be treated by injecting UMSCs in sub-tenon space of eye. Receives: Biological: Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa |
| Suprachoroidal injection group | Experimental | A total of twenty five subjects will be treated by suprachoroidal injection of UMSCs. Receives: Biological: Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety related adverse ocular events including immune response
No significant side effects in stem cell treated subjects
Measured: Baseline to day 360
Ophthalmic examination for best-corrected visual acuity (BCVA) using early treatment of diabetic retinopathy study (ETDRS) chart
Change in best corrected visual acuity (BCVA)
Measured: Baseline to day 360
Secondary outcomes (4)
Measurement of electrical activity/function of retina using Electroretinography (ERG) test
Change in electrical response/function of various cell types of retina
Measured: Baseline to day 360
Evaluation of outer retinal thickness using Optical Coherence Tomography (OCT) imaging test
Alteration in retinal thickness
Measured: Baseline to day 360
Examination of retinal damage by Fundus Photography
Change in retinal Fundus image
Measured: Baseline to day 360
Evaluation of visual field sensitivity using perimeter
Change in visual field sensitivity
Measured: Baseline to day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Retinitis Pigmentosa (RP)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Five (5) subjects will be treated by injecting UMSCs in sub-tenon space of eye. Group 2: Five (5) subjects will be treated by suprachoroidal injection of UMSCs . From two subjects in group 1 \& 2 will not be treated 24 hrs apart. Patients will be randomized in a 1:1 ratio (Sub-tenon injection of UMSCs : Suprachoroidal injection of UMSCs). Note: In total, twenty five patients will be subjected to cell injection for each of group 1 \& 2.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Burn and Reconstructive Surgery Centre, Lahore
- Sponsor type
- Other government
- Collaborators
- The Layton Rahmatullah Benevolent Trust (LRBT) Free Eye Hospital, Township Lahore., Centre of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore.
- Responsible party
- Principal investigator, Prof. Dr. Sheikh Riazuddin, Jinnah Burn and Reconstructive Surgery Centre, Lahore
- Investigators
- Sheikh Riazuddin, PhD, Principal investigator, Jinnah Burn & Reconstructive Surgery Center, LahoreZaheer-ud-Din A Qazi, consultant, Principal investigator, The Layton Rahmatullah Benevolent Trust (LRBT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04763369
- Sponsor's protocol ID
- JB&RSC-02
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kahraman NS, Oner A. Umbilical cord derived mesenchymal stem cell implantation in retinitis pigmentosa: a 6-month follow-up results of a phase 3 trial. Int J Ophthalmol. 2020 Sep 18;13(9):1423-1429. doi: 10.18240/ijo.2020.09.14. eCollection 2020.
PubMed 32953582Azam M, Collin RW, Malik A, Khan MI, Shah ST, Shah AA, Hussain A, Sadeque A, Arimadyo K, Ajmal M, Azam A, Qureshi N, Bokhari H, Strom TM, Cremers FP, Qamar R, den Hollander AI. Identification of novel mutations in Pakistani families with autosomal recessive retinitis pigmentosa. Arch Ophthalmol. 2011 Oct;129(10):1377-8. doi: 10.1001/archophthalmol.2011.290. No abstract available.
PubMed 21987686Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly derived mesenchymal stem cells: preliminary clinical results. Stem Cell Res Ther. 2020 Jan 13;11(1):25. doi: 10.1186/s13287-020-1549-6.
PubMed 31931872Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly-derived mesenchymal stem cells: prospective analysis of 1-year results. Stem Cell Res Ther. 2020 Aug 12;11(1):353. doi: 10.1186/s13287-020-01870-w.
PubMed 32787913Limoli PG, Vingolo EM, Morales MU, Nebbioso M, Limoli C. Preliminary study on electrophysiological changes after cellular autograft in age-related macular degeneration. Medicine (Baltimore). 2014 Dec;93(29):e355. doi: 10.1097/MD.0000000000000355.
PubMed 25546695Ali M, Mehmood A, Tarar MN, Nawaz Z, Riazuddin SA, Khan A, Riazuddin S. Efficacy of intravenous infusions of UC-derived MSCs for the treatment of COVID-19: A structured summary of a phase II double blinded, randomized controlled clinical trial. Preprint from Research Square, 28 Oct 2020. DOI: 10.21203/rs.3.rs-92995/v2
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Therapeutic Efficacy and Safety of Umbilical Cord Derived Mesenchymal Stem Cells (UMSCs) for the Management of Retinitis Pigmentosa (RP)
- ClinicalTrials.gov ID
- NCT04763369
- Acronym / sponsor ID
- JB&RSC-02
- Conditions
- Retinitis Pigmentosa (RP)
- Keywords
- Retinitis pigmentosa, Stem cells treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jinnah Burn and Reconstructive Surgery Centre, LahoreOther government
- Collaborators
- The Layton Rahmatullah Benevolent Trust (LRBT) Free Eye Hospital, Township Lahore., Centre of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore.
- Study start
- Feb 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 21 Feb 2021 (actual)
- 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.
Retinitis pigmentosa (RP) is the most common hereditary retinal disorder (accounts for 20% of children attending blind schools in Pakistan) which causes degeneration of rod and cone photoreceptors. Rods and cones largely depend on the retinal pigment epithelium for their proper functioning. Various growth factors and their receptors are present in retinal epithelium and a number of genes are responsible for the production of these growth factors. Genetic mutation in any of these genes causes retinal degeneration by progressive loss of retinal pigment epithelium and photoreceptors. The disease initially starts with night blindness and leads to the loss of central vision and eventually total blindness. To date, there is no definitive cure for patients suffering from RP. Recently, stem cell based therapies have shown great promise for the management of RP. It is well documented that umbilical cord derived mesenchymal stem cells (UMSCs) have the ability to release various paracrine and immunomodulatory factors that are similar to those synthesized by retinal pigment epithelium. Multiple routes including systemic (intravenous) and localized (subretinal, intravitreal, suprachoroidal and sub-tenon) have been employed to administer UMSCs for the management of RP. It is important to note that deep sub-tenon region (space between the sclera and the conjunctiva) acts as both natural culture medium for cells and as immune privileged site because of avascularity of the region. It has been reported that the injection of UMSCs in sub-tenon space of human subjects have improved the visual acuity even after 1 year post-injection. In addition, the injection of UMSCs in suprachoroidal space enhances the entry of growth factors released by the cells into choroidal flow and maintain the constant growth factors secretion to the choroidal and retinal tissues. Limoli and colleagues were the first to report the suprachoroidal administration of cells being the safe mode of cell delivery with no complications. The present study is aimed to investigate the safety and therapeutic efficacy of UMSC injection employing two different routes (sub-tenon injection versus suprachoroidal injection) for the treatment of RP in human subjects.
Detailed description
Isolation and characterization of human umbilical cord derived mesenchymal stem cells (UMSCs): The culturing and characterization of UMSCs will be performed as documented by Ali and colleagues. Briefly, human umbilical cord tissues along with informed consent forms will be collected from COVID-19- and hepatitis B, C virus-negative women with healthy pregnancies during the Cesarean Section surgery after completion of gestation period. The umbilical cord tissue will be transported in sterile 1x phosphate-buffered saline (PBS) containing penicillin and streptomycin on ice. In the biosafety cabinet, the cord will be washed with 4-5 changes of sterile 1x PBS and placed in a Petri plate with 15ml PBS. The cord will then gently scrap with a surgical blade to remove any dead cells. A 9 cm umbilical cord will be cut into three equal pieces and wash thoroughly to remove blood clots, umbilical cord arteries, and veins. Segments will be washed three times with PBS and minced. The minced pieces will be incubated in 17.5ml of collagenase solution (201 U/ml collagenase type I in serum-free DMEM-HG) in a 50ml conical tube for ~3 hrs in an incubator at 5% CO2, 95% humidity at 37oC. After ~3 hrs, the digested lysate will be passed through strainer and will be diluted three times with 1x PBS. Following centrifugation, the cells will be seeded into two T-25cm2 flasks and will be placed in an incubator at 5% CO2, 95% humidity at 37o C. The flasks will be fed with fresh media (DMEM-HG supplemented with 20% FBS and 1% antibiotic solution) every third day. At around day 18, cells will reach up to 85% confluency and will be transferred in two T-75cm2 flasks with media replaced at alternate days. UMSCs at P3 will be characterized using different specific antibodies. Cells at P3 will be employed for injection in RP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Five (5) subjects will be treated by injecting UMSCs in sub-tenon space of eye. Group 2: Five (5) subjects will be treated by suprachoroidal injection of UMSCs . From two subjects in group 1 \& 2 will not be treated 24 hrs apart. Patients will be randomized in a 1:1 ratio (Sub-tenon injection of UMSCs : Suprachoroidal injection of UMSCs). Note: In total, twenty five patients will be subjected to cell injection for each of group 1 \& 2.
| Arm | Type | Receives |
|---|---|---|
| Sub-tenon injection group | Experimental | Biological: Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosaIn total twenty five subjects will be treated by injecting UMSCs in sub-tenon space of eye. |
| Suprachoroidal injection group | Experimental | Biological: Injection of stem cells in suprachoroidal space of eye for the management of Retinitis PigmentosaA total of twenty five subjects will be treated by suprachoroidal injection of UMSCs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who will be voluntarily participated for UMSCs injection for the treatment of RP.
- Patients who will be able to adhere to the study follow-up and protocol requirements.
- Individuals with age ranges from 18 years to 70 years will be included.
- Patients with best corrected visual acuity (BCVA) from 50 letters to 110 letters or <20/50 in the ETDRS chart testing (Topcon CC-100 XP, Japan).
- Mean deviation values ranging between -33.0 and - 5.0 dB with compass visual field analysis (threshold 24-2, Sita Standard, Stimulus 3-white).
Key exclusion criteria (5 listed)
- Presence of cataracts or other media opacity that might affect the visual field, mean deviation, or electroretinogram recordings.
- Presence of another ocular disease except RP (i.e., uveitis, strabismus, glaucoma) that causes visual field and optic disc changes.
- Presence of any systemic disorder that may affect visual functions. This includes diabetes, neurological disorders, and uncontrolled systemic hypertension.
- Smokers will be excluded from the study.
- Individuals who underwent ocular surgery except cataract extraction will be considered as excluded.
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 |
|---|---|---|
| Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosaCultured stem cells will be injected in the sub-tenon space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360. | Biological | Sub-tenon injection group |
| Injection of stem cells in suprachoroidal space of eye for the management of Retinitis PigmentosaCultured stem cells will be injected in the suprachoroidal space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360. | Biological | Suprachoroidal injection group |
Primary outcome
Evaluation of safety related adverse ocular events including immune response
Time frame: Baseline to day 360
No significant side effects in stem cell treated subjects
Ophthalmic examination for best-corrected visual acuity (BCVA) using early treatment of diabetic retinopathy study (ETDRS) chart
Time frame: Baseline to day 360
Change in best corrected visual acuity (BCVA)
4 secondary outcomes
Measurement of electrical activity/function of retina using Electroretinography (ERG) test
Time frame: Baseline to day 360
Evaluation of outer retinal thickness using Optical Coherence Tomography (OCT) imaging test
Time frame: Baseline to day 360
Examination of retinal damage by Fundus Photography
Time frame: Baseline to day 360
Evaluation of visual field sensitivity using perimeter
Time frame: Baseline to day 360
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 32953582Kahraman NS, Oner A. Umbilical cord derived mesenchymal stem cell implantation in retinitis pigmentosa: a 6-month follow-up results of a phase 3 trial. Int J Ophthalmol. 2020 Sep 18;13(9):1423-1429. doi: 10.18240/ijo.2020.09.14. eCollection 2020.
- Background: PubMed 21987686Azam M, Collin RW, Malik A, Khan MI, Shah ST, Shah AA, Hussain A, Sadeque A, Arimadyo K, Ajmal M, Azam A, Qureshi N, Bokhari H, Strom TM, Cremers FP, Qamar R, den Hollander AI. Identification of novel mutations in Pakistani families with autosomal recessive retinitis pigmentosa. Arch Ophthalmol. 2011 Oct;129(10):1377-8. doi: 10.1001/archophthalmol.2011.290. No abstract available.
- Background: PubMed 31931872Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly derived mesenchymal stem cells: preliminary clinical results. Stem Cell Res Ther. 2020 Jan 13;11(1):25. doi: 10.1186/s13287-020-1549-6.
- Background: PubMed 32787913Ozmert E, Arslan U. Management of retinitis pigmentosa by Wharton's jelly-derived mesenchymal stem cells: prospective analysis of 1-year results. Stem Cell Res Ther. 2020 Aug 12;11(1):353. doi: 10.1186/s13287-020-01870-w.
- Background: PubMed 25546695Limoli PG, Vingolo EM, Morales MU, Nebbioso M, Limoli C. Preliminary study on electrophysiological changes after cellular autograft in age-related macular degeneration. Medicine (Baltimore). 2014 Dec;93(29):e355. doi: 10.1097/MD.0000000000000355.
- BackgroundAli M, Mehmood A, Tarar MN, Nawaz Z, Riazuddin SA, Khan A, Riazuddin S. Efficacy of intravenous infusions of UC-derived MSCs for the treatment of COVID-19: A structured summary of a phase II double blinded, randomized controlled clinical trial. Preprint from Research Square, 28 Oct 2020. DOI: 10.21203/rs.3.rs-92995/v2
- Individual participant dataSharing planned: Undecided
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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.
Sheikh Riazuddin, PhD principal investigator
Jinnah Burn & Reconstructive Surgery Center, Lahore
Zaheer-ud-Din A Qazi, consultant principal investigator
The Layton Rahmatullah Benevolent Trust (LRBT)
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 Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa and Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa in people with Retinitis Pigmentosa (RP), run by Jinnah Burn and Reconstructive Surgery Centre, Lahore at 1 site in Pakistan.
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 5 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 21 Feb 2021. 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 Pakistan. 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 Sheikh Riazuddin, PhD (+9242935164422, riazuddin@aimrc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of safety related adverse ocular events including immune response (time frame: Baseline to day 360). The study lists 2 primary outcomes in all. 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 NCT04763369, which also lists 6 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 21 Feb 2021.