NCT02687646

Brief Summary

Sequential administration of MSCs obtained from adipose tissue is an effective and safe treatment for acute graft versus host disease refractory to first-line treatment. Furthermore the infusion of these cells produces a biological pattern in patients that relates to the clinical response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

February 20, 2017

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

4.9 years

First QC Date

January 19, 2016

Last Update Submit

October 10, 2022

Conditions

Acute Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • Safety measured by incidence of serious adverse events

    Safety will be measured in terms of: Incidence of Serious Adverse Events after at the time of the infusion of study drug or during follow-up.

    2 years

Secondary Outcomes (1)

  • Effectiveness measured by answer of refractory acute graft disease against host to first-line treatment

    2 years

Study Arms (1)

Allogeneic Mesenchymal Cells

EXPERIMENTAL

All patients will receive Adult Allogeneic Mesenchymal Cell from adipose tissue. It is not considered ethical the inclusion of a control group.

Drug: Adult Allogeneic Mesenchymal cells from adipose tissue.

Interventions

Adult Allogeneic Mesenchymal cells from adipose tissue.DRUG

Study treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products. Subjects will receive four sequential IV dose of Mesenchymal stem cells. Sequential doses: Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg

Also known as: MSC for the treatment of graft -versus -host disease
Allogeneic Mesenchymal Cells

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ≥ grade II Graft Versus Host Disease refractory to first-line treatment.
  • Having been subjected to hematopoietic Stem Cell Transplantation as treatment for malignant blood disorder has been controlled by the transplantation. The source may have been bone marrow cells or peripheral blood (PB) and coming from a family member or unrelated donor.
  • Having been transplanted with myeloablative or non-myeloablative conditioning.
  • normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process
  • Lung function without evidence of severe obstructive or restrictive lung disease.
  • Age between 18 and 65 years.
  • normal cardiac function (EF ≥ 40%) without evidence of uncontrolled hypertension, congestive heart failure, angina pectoris or myocardial infarction within 6 months prior to the process.
  • Signature of informed consent -

You may not qualify if:

  • bacterial, viral, fungal or is not being controlled.
  • Any circumstance that the proposed trial dissuade medical treatment. Pregnancy, lactation or refusal to use safe contraceptive measures.
  • Patients who are currently participating or have completed their participation in a clinical trial in less than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time period.
  • Patients who are currently participating or have completed their participation in a clinical trial in a period shorter than 3 months or who have participated in a clinical trial of Advanced Therapies at any previous time.
  • positive serology for Hepatitis B , Hepatitis C and AIDS Virus. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinica Universitaria de Navarra, Av Pio XII ,36

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Regional Universitario de Málaga

Málaga, Spain

Location

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

Hospital clinico universitario de salamanca

Salamanca, 37007, Spain

Location

Virgen del Rocio University Hospital, av. Manuel Siurot s/n

Seville, 41013, Spain

Location

Study Officials

  • Teresa Caballero, Hematologist

    Virgen del Rocio University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

February 22, 2016

Study Start

February 20, 2017

Primary Completion

January 21, 2022

Study Completion

January 21, 2022

Last Updated

October 13, 2022

Record last verified: 2022-10

Locations

ES(6)