NCT01585857

Brief Summary

Primary: To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA). Secondary: To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2012

Typical duration for phase_1

Geographic Reach
2 countries

2 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

March 19, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

2.7 years

First QC Date

March 19, 2012

Last Update Submit

December 21, 2022

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Recording of Serious Adverse Events

    Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.

    during 365 days following injection

Secondary Outcomes (2)

  • Functional status of the knee

    during 365 days following injection

  • Evaluation of Quality of life

    during 365 days following injection

Study Arms (3)

Group 1

EXPERIMENTAL

2 x 10E6 ASC intra-articular injection (5 ml)

Biological: Autologous adipose derived stem cells administrated for intra-articular use

Group 2

EXPERIMENTAL

10 x 10E6 ASC intra-articular injection (5 ml)

Biological: Autologous adipose derived stem cells administrated for intra-articular use

Group 3

EXPERIMENTAL

50 x 10E6 ASC intra-articular injection (5 ml)

Biological: Autologous adipose derived stem cells administrated for intra-articular use

Interventions

Autologous adipose derived stem cells administrated for intra-articular useBIOLOGICAL

Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.

Group 2Group 3

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.

You may not qualify if:

  • Any disease or medication affecting the bone or cartilage metabolism, including corticoids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UH Montpellier

Montpellier, 34295, France

Location

Orthopädische Klinik

Würzburg, 97074, Germany

Location

Related Publications (1)

  • Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.

    PMID: 27217345DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Christian Jorgensen, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

April 26, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 23, 2022

Record last verified: 2022-12

Locations

DE(1)FR(1)