ADIPOA - Clinical Study

University Hospital Center (CHU)

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01585857

8606

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Group 1

Experimental group

Description:

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

Treatment:

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

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

Group 2

Experimental group

Description:

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

Treatment:

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

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

Group 3

Experimental group

Description:

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

Treatment:

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

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