ADIPOA - Clinical Study

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: Autologous adipose derived stem cells administrated for intra-articular use

• Registration Number: NCT01585857
• Lead Sponsor: University Hospital, Montpellier

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-19
• Study Start: 2012-04
• Study First Submitted QC: 2012-04-24
• Study First Posted: 2012-04-26
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	Autologous adipose derived stem cells administrated for intra-articular use	50 x 10E6 ASC intra-articular injection (5 ml)
Group 2	Autologous adipose derived stem cells administrated for intra-articular use	10 x 10E6 ASC intra-articular injection (5 ml)
Group 1	Autologous adipose derived stem cells administrated for intra-articular use	2 x 10E6 ASC intra-articular injection (5 ml)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Evaluation of 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.

Trial Locations

Locations (2)

UH Montpellier; 🇫🇷 Montpellier, France

Orthopädische Klinik; 🇩🇪 Würzburg, Germany