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Stem Cell Therapy
Stem Cell Therapy for Age-Related Macular Degeneration
Phase 1
Recruiting
Research Sponsored by Astellas Institute for Regenerative Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be willing to take tacrolimus and willing to discontinue any medications that have a known strong interaction with tacrolimus.
Participant is able and willing to undertake all scheduled visits and assessments up to the week 52 visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 1, 4, 6, 8, 12, 16, 26 and 52/end of study (eos)
Awards & highlights
Study Summary
This trial is for adults 50+ who are losing their vision due to dry age-related macular degeneration. A new treatment, ASP7317, which is a specially created type of cell derived from human stem cells, will be injected into the macula of the eye in an effort to slow or reverse atrophy.
Who is the study for?
Adults over 50 with dry age-related macular degeneration (dry AMD) and geographic atrophy, resulting in central vision loss. Participants must be willing to discontinue certain supplements and medications, agree to use contraception if of childbearing potential, and not have a history of certain eye treatments or conditions that could affect the study's outcome.Check my eligibility
What is being tested?
The safety and effectiveness of ASP7317, a new cell-based therapy for dry AMD are being tested. Patients will receive one of three different doses via injection into the eye under anesthesia. They'll also take tacrolimus orally to prevent rejection of these cells. The trial includes frequent clinic visits for monitoring.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to stem cell transplantation and immunosuppression from tacrolimus such as increased infection risk, possible organ inflammation, or other complications associated with surgery under anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to take tacrolimus and stop any medications that strongly interact with it.
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I can attend all appointments and assessments for up to 52 weeks.
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I will not donate eggs for one year after the last treatment.
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I am willing to take tacrolimus and stop any medications that strongly interact with it.
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I have advanced age-related vision loss in both eyes.
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My vision ranges from light perception to reading a few letters for Cohort 1, or is very poor but not complete blindness for Cohorts 2 and 3.
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I am on long-term medication for an infection.
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I have had a solid organ or bone marrow transplant.
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I cannot use systemic immunosuppressants like tacrolimus.
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I had a heart attack in the last year and my heart condition is unstable or causes symptoms.
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My kidney function, measured by eGFR, is 45 mL/min or lower.
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I have a serious blood clotting disorder.
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I have a history of familial adenomatous polyposis or inflammatory bowel disease.
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I have never participated in gene or cell transplant therapy trials.
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I am willing to stop taking certain medications while on tacrolimus.
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My vision loss is not due to age-related macular degeneration.
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I have had eye surgery for AMD or similar conditions.
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I have had treatments like photodynamic therapy or radiation for my eyes.
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I have had laser treatment for serious eye conditions.
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I have an eye condition that affects the thickness or structure of my macula.
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I have a history of specific serious eye conditions.
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I have or had eye inflammation issues like uveitis.
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I have a scar from eye toxoplasmosis.
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I have a high-risk eye mole or lesion.
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I have severe nearsightedness or related eye conditions.
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I have glaucoma that is not controlled, use more than 2 medications for it, or had surgery for it.
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I have had a corneal transplant.
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I can only see with one eye or I have lost an eye.
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I have an eye condition that affects vision tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, weeks 1, 4, 6, 8, 12, 16, 26 and 52/end of study (eos)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 1, 4, 6, 8, 12, 16, 26 and 52/end of study (eos)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of cellular graft failure or rejection
Number of participants with cellular graft failure or rejection
Safety as assessed by incidence, frequency and severity of Serious Adverse Events (SAEs)
+2 moreSecondary outcome measures
Mean change from baseline in PWS in junctional zone
Mean change from baseline in PWS in remote zone
Mean change from baseline in area of Geographic Atrophy (GA) (mm^2) in study eye and fellow eye
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: ASP7317 Dose Escalation/ Expansion (Group 2: Moderate Vision Loss)Experimental Treatment5 Interventions
Successive cohorts of participants (3 participants each) will be given escalating doses (cohort 4: low cells/dose; cohort 5: medium cells/dose; cohort 6: high cells/dose).
Expansion cohorts 5b and 6b (6 participants each) will be opened after cohorts 5 and 6 have been filled. Dose levels for the expansion cohorts will align with dose levels in escalation cohorts. Cohort 4 (low cells/dose) dosing may begin after the DSMB recommendation to begin dosing in Group 1 cohort 2 (medium cells/dose).
Cohort 5 (medium cells/dose) dosing may begin after DSMB review of the 4 week safety data of the first participant in Group 1 cohort 2 (medium cells/dose). Cohort 6 (high cells/dose) dosing may begin after DSMB review of 4 week safety data of the first participant in Group 1 cohort 3 (high cells/dose). Dosing in cohort 5 and 6 can only begin after the DSMB review and the completion of the preceding cohort. Participants will receive tacrolimus and other medicines to stop infection.
Group II: ASP7317 Dose Escalation/ Expansion (Group 1: Severe Vision Loss)Experimental Treatment5 Interventions
Successive cohorts of participants (3 participants each) will be given escalating doses (cohort 1: low cells/dose; cohort 2: medium cells/dose; cohort 3: high cells/dose). Expansion cohorts (6 participants each) 3b will be opened after cohort 3 has been filled and 2b will be opened only if necessary. Dose levels for the expansion cohort will align with dose levels in escalation cohorts.
Sentinel dosing will be required for each dose level. After the first participant in Group 1 dose cohort is dosed and followed for 4 weeks, the Data Safety Monitoring Board (DSMB) will review the 4 week safety data and recommend if the second and third participants in Group 1 dose cohort may be treated.
The DSMB recommendation to progress to the next dosing cohort will be based on 4 week follow-up safety review of the second and third participants in the preceding dose cohort. Participants will receive tacrolimus and other medicines to stop infection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
trimethoprim-sulfamethoxazole
2020
Completed Phase 4
~2920
Acyclovir
2005
Completed Phase 4
~5180
Nystatin
2012
Completed Phase 4
~520
tacrolimus
2004
Completed Phase 4
~3750
Find a Location
Who is running the clinical trial?
Astellas Institute for Regenerative MedicineLead Sponsor
8 Previous Clinical Trials
110 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,822 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to breastfeed during the study and for a year after the last dose.I will not donate eggs for one year after the study treatment.I will not have unprotected sex if my partner is pregnant, during the study, and for a year after the last dose.I have advanced age-related vision loss in both eyes.I am willing to stop taking my AMD vitamins/supplements for a specific period around my treatment.I have or might have an active toxoplasmosis infection.I am on long-term medication for an infection.I cannot use systemic immunosuppressants like tacrolimus.I had a heart attack in the last year and my heart condition is unstable or causes symptoms.I have an eye condition that affects the thickness or structure of my macula.I have a history of specific serious eye conditions.I have or had eye inflammation issues like uveitis.I have a scar from eye toxoplasmosis.I have severe nearsightedness or related eye conditions.I have glaucoma that is not controlled, use more than 2 medications for it, or had surgery for it.I have an eye condition that affects vision tests.My kidney function, measured by eGFR, is 45 mL/min or lower.I will not donate sperm during or for a year after treatment.You have had surgery to remove cataracts and have an artificial lens.My vision loss is not due to age-related macular degeneration.You have had an allergic reaction to eye drops used during eye exams.You have taken part in a research study involving new drugs within the past 12 weeks.I am on a stable dose of antidepressants and willing to continue taking them.I haven't taken any immune therapies in the last 6 weeks or 5 half-lives.You are not a woman who can become pregnant.I am not pregnant and either cannot become pregnant or am following birth control advice.I am a man and will use birth control during and for a year after treatment.I am willing and able to undergo anesthesia for eye surgery.I am on a stable antidepressant dose and will continue taking it.I have never participated in gene or cell transplant therapy trials.I am willing to stop taking certain medications while on tacrolimus.I am willing to take tacrolimus and stop any medications that strongly interact with it.I can attend all appointments and tests for a year.I have had CMV infection again or was diagnosed with it in the last 4 weeks.I have had eye surgery for AMD or similar conditions.I have had treatments like photodynamic therapy or radiation for my eyes.A woman who agrees to follow the contraceptive guidance from the time of informed consent through at least 52 weeks after investigational product (IP) administration is a WOCBP.I am willing and able to have anesthesia for eye surgery.I have had laser treatment for serious eye conditions.I have a high-risk eye mole or lesion.I have had a corneal transplant.I have had chickenpox or shingles more than once or diagnosed with it in the last 4 weeks.My vision ranges from light perception to reading a few letters for Cohort 1, or is very poor but not complete blindness for Cohorts 2 and 3.I have had a solid organ or bone marrow transplant.I have a history of familial adenomatous polyposis or inflammatory bowel disease.I can only see with one eye or I have lost an eye.I am willing to take tacrolimus and stop any medications that strongly interact with it.I haven't had cancer in the past 5 years, except for specific non-spreading skin cancers or early cervical cancer.I have not had eye injections in the last year.I have a serious blood clotting disorder.The general inclusion criteria are met.My eyes can be clearly imaged for a fundus exam.You promise not to take part in another study that involves treatment until the 52-week visit in this study is over.I can attend all appointments and assessments for up to 52 weeks.I agree not to breastfeed during and for 52 weeks after the study.I will not donate eggs for one year after the last treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ASP7317 Dose Escalation/ Expansion (Group 1: Severe Vision Loss)
- Group 2: ASP7317 Dose Escalation/ Expansion (Group 2: Moderate Vision Loss)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Age-Related Macular Degeneration Patient Testimony for trial: Trial Name: NCT03178149 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this investigation for volunteers?
"Data hosted on clinicaltrials.gov affirms that this medical trial is currently searching for participants, with the initial post date being July 13th 2018 and the last update being made September 23rd 2022."
Answered by AI
What is the principal objective of this research project?
"This clinical trial aims to determine the safety of an intervention by assessing Serious Adverse Events (SAEs) over a period up to 52 weeks. Secondary objectives involve measuring changes in Geographic atrophy (GA) area and square root transformation of GA area through blue-light, near-infrared fundus autofluorescence, and spectral domain-optical coherence tomography techniques."
Answered by AI
How many participants have been accepted for this research endeavor?
"This trial requires 18 patients who meet the inclusion criteria to join. Those chosen can visit Retina Specialty Institute in Pensacola, Florida and Emory University Eye Center in Atlanta, Georgia for enrollment purposes."
Answered by AI
What prior research has been done concerning the efficacy of ASP7317?
"Demonstrating the extensive research conducted on ASP7317, 150 clinical trials are in progress. Of those live studies, 18 have entered Phase 3 testing and 871 sites across America are running them. While many of these assessments take place in Nashville, Tennessee; others occur elsewhere."
Answered by AI
Has the FDA granted clearance to ASP7317?
"As this is a Phase 1 trial, meaning there are no prior clinical studies that demonstrate efficacy and limited evidence of safety, ASP7317 has been given an estimated rating of 1."
Answered by AI
To what maladies is ASP7317 most frequently employed?
"Often prescribed to manage dermatitis atopic, ASP7317 can be beneficial in treating other diseases such as liver transplant rejection, kidney transplant rejection, and psoriasis."
Answered by AI
Who else is applying?
What state do they live in?
Mississippi
Florida
Other
Alabama
How old are they?
18 - 65
65+
What site did they apply to?
Jules Stein Eye Institute
Emory University Eye Center
Other
Retina Specialty Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What questions have other patients asked about this trial?
Yes. I actually have Stargardts, rather than age-related macular degeneration. My sight is still fairly good but obviously going in the wrong direction. The trial treatment on the face of it would seem to be potentially beneficial, Am I still eligable?
PatientReceived no prior treatments
Why did patients apply to this trial?
I've been looking for studies that may help me retain the ability to see as well as possible. I believe that this therapy would enable me to see music well enough to play the organ and piano again. I'm veery happy to find this study and hope that I will quality.
PatientReceived 2+ prior treatments
Although I have known for several years that my eyes have some macular degeration when I have an eye exam, I did not, until recently, experience AMD symptoms. For example, I can no lonnger see the center of the night sky. Of course, I've been concerned and do what can (AAREDS and Lutein). My genetic heritage does place me at greater risk of AMD. My mother and her three sisters all had AMD, but none of my cousins do. I keep up with AMD research...now seems to be a good time to join a research trial. I retired as a public health epidemiologist 20 years ago....and would love to do what I can to help myself and others.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Retina Specialty Institute: < 24 hours
- Emory University Eye Center: < 48 hours
- Stanford University Byers Eye Institute: < 48 hours
Average response time
- < 2 Days
Typically responds via
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