ADIPOA - Clinical Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01585857

Enrollment

Registered

2012-04-26

Start date

2012-04-30

Completion date

2014-12-31

Last updated

2022-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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).

Interventions

BIOLOGICALAutologous 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026