Evaluation of GvHD Damage on Medullary Mesenchymal Stem C... | NCT05167188

Studies
Evaluation of GvHD Damage on Medullary Mesenchymal Stem Cells

NCT05167188

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Status

Unknown status

Last Update Posted

May 24, 2023Actual

Enrollment

25Estimated

Phase

Not provided

Conditions

Graft Vs Host Disease

Interventions

no intervention

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2021Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Nov 24, 2021

First Submission Date that Met QC Criteria

Dec 7, 2021

First Posted Date

Dec 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 24, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Franca Fagioli, Prof., Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Spontaneous, multicenter, prospective, non-pharmacological study. At the diagnosis of acute or chronic GvHD after HSCT, bone marrow cells will be analysed for MSC content and properties. Bone marrow aspirate will be performed according to usual clinical practise

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25Estimated

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of damage generated by acute or chronic GvHD on the MSCs after HSCT		Through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients (children and adults) developing acute or chronic GvHD after HSCT.
Age 6 months- month-99 years,
Landsky-Karnofsky> 70%,
Acute or chronic GvHD needing further immunosuppressive treatment.

Exclusion Criteria:

Anything not included in the inclusion criteria.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients (children and adults) developing acute or chronic GvHD after HSCT

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Franca Fagioli, MD	Contact	+39011313	5997	franca.fagioli@unito.it
Massimo Berger, MD	Contact	+39011313	5997	massimoberger@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Città della Salute e della Scienza di Torino	Recruiting	Torino		10126	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006086	Graft vs Host Disease

Ancestor Terms

ID	Term
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided