ADIPOA - Clinical Study

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT01585857

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Biological: Autologous adipose derived stem cells administrated for intra-articular use Biological: Autologous adipose derived stem cells administrated for intra-articular use	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 2 x 10E6 ASC intra-articular injection (5 ml)	Biological: Autologous adipose derived stem cells administrated for intra-articular use 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. The first patient will be followed during 12 weeks before inclusion of the second patient.
Experimental: Group 2 10 x 10E6 ASC intra-articular injection (5 ml)	Biological: Autologous adipose derived stem cells administrated for intra-articular use 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.
Experimental: Group 3 50 x 10E6 ASC intra-articular injection (5 ml)	Biological: Autologous adipose derived stem cells administrated for intra-articular use 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.

Arm

Intervention/Treatment

Experimental: Group 1

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

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

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. The first patient will be followed during 12 weeks before inclusion of the second patient.

Experimental: Group 2

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

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

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.

Experimental: Group 3

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

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

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.

Outcome Measures

Primary Outcome Measures

Recording of Serious Adverse Events [during 365 days following injection]
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.

Secondary Outcome Measures

Functional status of the knee [during 365 days following injection]
Efficacy will be assessed by measuring: WOMAC (Western Ontario and McMaster Universities osteoarthritis index), Short Arthritis assessment Scale (SAS), range of motion of the target knee joint, imaging through MRI evaluation, dGEMRIC and T1rho MRI.
Quality of life [during 365 days following injection]
Quality of life will be assessed by measuring: pain-specific assessment global patient assessment (visual analog scale, Short-Form 8) decrease in rescue paracetamol medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UH Montpellier	Montpellier		France	34295
2	Orthopädische Klinik	Würzburg		Germany	97074

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Principal Investigator: Christian Jorgensen, MD, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT01585857

Other Study ID Numbers:

8606

First Posted:

Apr 26, 2012

Last Update Posted:

Dec 4, 2014

Last Verified:

Dec 1, 2014

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of Dec 4, 2014