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EXG34217 for Bone Marrow Failure Syndrome
Phase 1
Waitlist Available
Led By Kasiani Myers, MD
Research Sponsored by Elixirgen Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline systolic blood pressure at month 18, 24,30,36,42,48,60 and 72
Awards & highlights
Study Summary
This trial is studying long-term effects of a medical treatment.
Who is the study for?
This trial is for individuals with Bone Marrow Failure Syndrome, Pancytopenia, or Telomere Biology Disorders who have completed a previous study (EXG-US-01) and are willing to follow the new study's procedures.Check my eligibility
What is being tested?
The intervention being studied is EXG34217. This trial serves as a long-term follow-up from an earlier Phase I/II study to monitor ongoing effects and gather more data on safety and efficacy.See study design
What are the potential side effects?
Specific side effects of EXG34217 are not listed here, but they may include typical reactions related to bone marrow treatments such as fatigue, infection risk increase, bleeding complications, or other organ-related issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline systolic blood pressure at month 18, 24,30,36,42,48,60 and 72
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline systolic blood pressure at month 18, 24,30,36,42,48,60 and 72
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with a change in Electrocardiography (ECG)
Number of participants with a change in clinical laboratory evaluations
Number of participants with a change of Immunogenicity
+2 moreSecondary outcome measures
Number of participants with a change in telomere length
Number of participants with improvement of blood counts.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EXG34217Experimental Treatment1 Intervention
single autologous CD34+ cells contacted ex vivo with EXG-001
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Who is running the clinical trial?
Elixirgen Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
52 Total Patients Enrolled
Kasiani Myers, MDPrincipal InvestigatorCincinnati Children Hospital Medical Center
2 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: EXG34217
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned EXG34217 for public use?
"The estimated safety of EXG34217 is a 1, as this Phase 1 trial has only provided limited data demonstrating the drug's efficacy and security."
Answered by AI
Are there any opportunities available to join this research endeavor?
"According to the information in clinicaltrials.gov, this trial is no longer enrolling participants. Initially posted on July 1st 2023, it was last updated May 18th 2023 and is not currently available for participation. However, there are 27 other studies that are recruiting patients presently."
Answered by AI
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