Trial Outcomes & Findings for Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma. (NCT NCT02330978)
NCT ID: NCT02330978
Last Updated: 2019-07-08
Results Overview
Retinal detachment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
6 months
Results posted on
2019-07-08
Participant Flow
The study requisits to enroll patients are too tight and some patients selected do not atend to all admision requisits like vision acuity worse than 20/100 in both eyes, absence of systemic comorbidities, etc.
Participant milestones
| Measure |
MSC Transplantion
One group of glaucomatous patients will receive 10(6) autologous bone marrow-derived mesenchymal stem cells transplantation into their worst eye, through an unique intravitreal injections, under anesthesia.
Intravitreal transplantation of mesenchymal stem cell
Culture and isolation of autologous bone-marrow mesenchymal stem cells
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|---|---|
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The First Patient Included at Study
STARTED
|
1
|
|
The First Patient Included at Study
COMPLETED
|
1
|
|
The First Patient Included at Study
NOT COMPLETED
|
0
|
|
The Second Patient Included at Study
STARTED
|
1
|
|
The Second Patient Included at Study
COMPLETED
|
1
|
|
The Second Patient Included at Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravitreal Mesenchymal Stem Cell Transplantation in Advanced Glaucoma.
Baseline characteristics by cohort
| Measure |
The First Patient Included at Study
n=2 Participants
On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
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1 Participants
n=93 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=93 Participants
|
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Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
Brazil
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2 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsRetinal detachment
Outcome measures
| Measure |
The First Patient Included at Study
n=1 Participants
On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
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|---|---|
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Type and Severity of Adverse Effects (AE) and Adverse Reactions (AR)
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1 Participants
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SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
The First Patient Included at Study
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
The First Patient Included at Study
n=2 participants at risk
On the thirtieth day after the vitreous injection a combined serous retinal detachment with proliferative vitreoretinopathy was noticed in patient 1 - promptly treated with a successful pars plana vitrectomy and silicone oil tamponade. At the final follow-up period (12 months), he remained with no retinal detachment and light perception vision.
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|---|---|
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Eye disorders
Retinal detachment
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50.0%
1/2 • Number of events 1
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place