NCT04153630|UnknownPhase 1/2
Loading search results
Sponsor study identifier
interventional
9
1 country
1
Study Start
May 17, 2018
Actual (reported)Primary Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Phase I / II pilot clinical trial, to evaluate the safety and preliminary efficacy of the systemic infusion of mesenchymal stem cells derived from bone marrow (BM-MSCs) from a haploidentical donor to improve the healing process and / or the mucocutaneous fragility phenotype associated with EBDR.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2018
Actual (reported)August 6, 2019
Actual (reported)November 6, 2019
Actual (reported)March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Safety evaluation: Incidence of Treatment-Emergent Adverse Events as assessed by protocol.
To evaluate the safety of haploidentical MSCs derived from bone marrow administered by intravenous injection with a dose of 2-3x106 cells / Kg in 3 infusions separated by 21 days each for the treatment of patients with RDEB: All adverse events will be registered for 1 year from first infusion of cells as assessed by grade: mild, moderate or severe (according to protocol)
1 year after infusion
Cutaneous mechanical resistance
2 year after infusion
Skin surface affected
2 year after infusion
Number of blisters
2 year after infusion
Non-specific general markers of systemic inflammation: white blood cell count
2 year after infusion
Non-specific general markers of systemic inflammation: Negative acute phase reactant (albumin)
2 year after infusion
Haploidentical MSCs derived from bone marrow administered by intravenous injection with a dose of 2-3x106 cells / Kg
Procedure: Haploidentical MSCs derived from bone marrow administered by intravenous injection with a dose of 2-3x106 cells / Kg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario La Paz
Madrid, 28046, Spain
Maseda R, Arriba MC, Martinez-Santamaria L, Jimenez E, Herraiz-Gil S, Illera N, Quintana-Castanedo L, Garcia M, Suarez-Sancho S, Yanez R, Perez-Conde I, Carretero M, Martinez-Queipo M, de Paz R, Leon C, Jimenez-Yuste V, Borobia AM, Vicente A, Lwin SM, McGrath JA, Fernandez-Santos ME, Butta N, Sacedon R, Del Rio M, de Lucas R, Escamez MJ. MesenSistem-EB: systemic haploidentical mesenchymal stem cell therapy in recessive dystrophic epidermolysis bullosa associated with clinical benefits and correlated with MCP1 and sCD40L dynamics. Front Immunol. 2026 May 5;17:1789537. doi: 10.3389/fimmu.2026.1789537. eCollection 2026.
9 participants (actual enrollment reported by the registry).
First Submitted
August 6, 2019
First Posted
November 6, 2019
Study Start
May 17, 2018
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 8, 2019
Record last verified: 2019-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: