Age-Related Macular DegenerationPhase 2RADIANTNCT02467634
Study of HUCNS-SC Subretinal Transplantation in Subjects With GA of AMD
A Phase 2 study testing HuCNS-SC sub-retinal transplantation in people with Age-Related Macular Degeneration, run by StemCells, Inc. at 12 sites in United States.
Trial summary
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- HuCNS-SC sub-retinal transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2015to May 2016
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.
- BCVA of 20/320 or better in each eye at screening assessment
Who cannot join
- Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.
- Retinal or macular disease of any other cause in either eye.
- Diagnosis of glaucoma in either eye.
- Uncontrolled intraocular pressure in either eye
- Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection.
- History of or active autoimmune disease.
- Previous organ, tissue or bone marrow transplantation.
- Seropositive for HIV, hepatitis B or C, or CMV IgM
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Retina Research Center
Austin, Texas, 78705
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retinal Diagnostic Center
Campbell, California, 95008
Rush University Med Ctr.
Chicago, Illinois, 60612
Retina Foundation of the Southwest
Dallas, Texas, 75231
Northern California Retina Vitreous Associates
Mountain View, California, 94040
New York Eye and Ear Infirmary
New York, New York, 10003
Retina Research Institute of Texas
Palo Alto, California, 94303
William Beaumont Health System
Royal Oak, Michigan, 48073
University Of Utah / John A. Moran Eye Center
Salt Lake City, Utah, 84132
Retina Associates Southwest, PC
Tucson, Arizona, 85724
About this study
Official title: A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
Read the detailed description
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- HuCNS-SC sub-retinal transplantation
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuCNS-SC sub-retinal transplantationBiological
HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD
| Study group | Role | What they receive |
|---|---|---|
| HuCNS-SC | Experimental | HuCNS-SC sub-retinal transplantation Receives: Biological: HuCNS-SC sub-retinal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
GA area based on fundus autofluorescence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Based on a business decision unrelated to any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- StemCells, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel Naor, MD, Study chair, StemCells, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467634
- Sponsor's protocol ID
- CL-AMD-201
- Acronym
- RADIANT
- Status last verified
- May 2016
- First submitted
- 4 Jun 2015
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Proof-of-Concept Study of the Safety and Efficacy of HUCNS-SC Subretinal Transplantation in Subjects With Geographic Atrophy of Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02467634
- Acronym / sponsor ID
- RADIANT / CL-AMD-201
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on a business decision unrelated to any safety concerns.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- StemCells, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Jun 2015 (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.
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation.
Detailed description
A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HuCNS-SC | Experimental | Biological: HuCNS-SC sub-retinal transplantationHuCNS-SC sub-retinal transplantation |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GA associated with AMD in both eyes. Total area of GA determined by fundus autofluorescence.
- BCVA of 20/320 or better in each eye at screening assessment
Key exclusion criteria (8 listed)
- Prior or concurrent choroidal neovascularization in either eye by clinical exam and/or fluorescein angiography as determined by the investigator or the reading center.
- Retinal or macular disease of any other cause in either eye.
- Diagnosis of glaucoma in either eye.
- Uncontrolled intraocular pressure in either eye
- Compromised renal function defined as eGFR <60mL/min and urine protein-to-creatinine ration >0.3 is spot urine collection.
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 |
|---|---|---|
| HuCNS-SC sub-retinal transplantationHuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD | Biological | HuCNS-SC |
Primary outcome
GA area based on fundus autofluorescence
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Based on a business decision unrelated to any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
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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.
Joel Naor, MD study chair
StemCells, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HuCNS-SC sub-retinal transplantation in people with Age-Related Macular Degeneration, run by StemCells, Inc. at 12 sites in United States.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
The study was stopped early (reason given: Based on a business decision unrelated to any safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GA area based on fundus autofluorescence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2016.