Long Term Follow-Up Study for Individuals With Hemoglobin Disorders After Hematopoietic Cell Transplant or Gene Therapy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This is a prospective, longitudinal, non-therapeutic study which includes routine assessment for long-term effects, as per FDA guidelines after receipt of an allogeneic HCT or autologous genetically modified cellular products for hemoglobin disorders. Primary objective: \- To provide long term follow up, for individuals with hemoglobin disorders undergoing allogeneic hematopoietic stem cell transplantation (HCT) or receipt of an autologous genetically modified cellular product to treat their hemoglobinopathy. For individuals receiving a genetically modified cellular product, this long term follow up study is in accordance with the guidelines provided by the Food and Drug Administration (FDA).

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Receipt, or planned receipt, of an allogeneic HSCT or infusion of genetically modified autologous cells for hemoglobin disorders within 15 years prior to enrollment

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Akshay Sharma, MD
referralinfo@stjude.org
8662785833
Backup
Neha Das Gupta, PhD
referralinfo@stjude.org
8662785833
Time Frame
Start Date: 2025-06-26
Estimated Completion Date: 2050-01
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: St. Jude Children's Research Hospital

This content was sourced from clinicaltrials.gov