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ADIPOA - Clinical Study

NCT ID: NCT01585857

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Autologous adipose derived stem cells administrated for intra-articular use

Intervention Type BIOLOGICAL

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.

Group 2

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

Group Type EXPERIMENTAL

Autologous adipose derived stem cells administrated for intra-articular use

Intervention Type BIOLOGICAL

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 3

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

Group Type EXPERIMENTAL

Autologous adipose derived stem cells administrated for intra-articular use

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Jorgensen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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UH Montpellier

Montpellier, , France

Site Status

Orthopädische Klinik

Würzburg, , Germany

Site Status

Countries

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France Germany

References

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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.

Reference Type DERIVED
PMID: 27217345 (View on PubMed)

Other Identifiers

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8606

Identifier Type: -

Identifier Source: org_study_id