NCT02849613

Brief Summary

Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 6, 2021

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

July 6, 2016

Last Update Submit

September 28, 2021

Conditions

Stroke

Keywords

cell therapystem celltransplantationgraftrecoveryrepairstrokemesenchymal stem cellregenerative

Outcome Measures

Primary Outcomes (1)

  • Between-group difference of NIHSS (stroke severity score)

    6 months after stroke onset

Study Arms (2)

Adipose derived Stem Cells ADSC

EXPERIMENTAL

ADSC, single IV, 1.106 cells/kg

Other: Adipose Derived Stem Cells

Vehicle media

SHAM COMPARATOR

IV infusion of cell excipients, 1ml/kg

Other: Vehicle media

Interventions

Adipose Derived Stem CellsOTHER
Also known as: ADSC
Adipose derived Stem Cells ADSC
Vehicle mediaOTHER
Also known as: Placebo
Vehicle media

Eligibility Criteria

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

You may qualify if:

  • Hemispheric ischemic stroke (\>1.5cm)
  • NIHSS \> or = 7
  • No craniectomy
  • Able to follow a rehabilitation program
  • Modified Rankin scale = 0 before stroke onset

You may not qualify if:

  • Coma
  • Severe leucoariosis
  • Previous stroke
  • Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV
  • History of cancer
  • Pregnancy, breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Grenoble Hospital / EFS

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Olivier DETANTE, MD PhD

    University Hospital Grenoble-Alpes, France

    PRINCIPAL INVESTIGATOR

  • Exuperio DIEZ TEJEDOR, MD PhD

    La Paz University Hospital, Madrid, Spain

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 29, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 6, 2021

Record last verified: 2016-07

Locations

FR(1)