OsteoarthritisPhase 1NCT01585857
ADIPOA - Clinical Study
A Phase 1 study testing Autologous adipose derived stem cells administrated for intra-articular use in people with Osteoarthritis, run by University Hospital, Montpellier at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Autologous adipose derived stem cells administrated for intra-articular use
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2012to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any disease or medication affecting the bone or cartilage metabolism, including corticoids.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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).
- Conditions
- Osteoarthritis
- Being tested
- Autologous adipose derived stem cells administrated for intra-articular use
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose derived stem cells administrated for intra-articular useBiological
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.
Autologous adipose derived stem cells administrated for intra-articular useBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 2 x 10E6 ASC intra-articular injection (5 ml) Receives: Biological: Autologous adipose derived stem cells administrated for intra-articular use |
| Group 2 | Experimental | 10 x 10E6 ASC intra-articular injection (5 ml) Receives: Biological: Autologous adipose derived stem cells administrated for intra-articular use |
| Group 3 | Experimental | 50 x 10E6 ASC intra-articular injection (5 ml) Receives: Biological: Autologous adipose derived stem cells administrated for intra-articular use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recording of Serious Adverse Events
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.
Measured: during 365 days following injection
Secondary outcomes (2)
Functional status of the knee
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.
Measured: during 365 days following injection
Evaluation of Quality of life
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.
Measured: during 365 days following injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Jorgensen, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585857
- Sponsor's protocol ID
- 8606
- Status last verified
- Dec 2022
- First submitted
- 19 Mar 2012
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27217345
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01585857
- Acronym / sponsor ID
- 8606
- Conditions
- Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Autologous adipose derived stem cells administrated for intra-articular use2 x 10E6 ASC intra-articular injection (5 ml) |
| Group 2 | Experimental | Biological: Autologous adipose derived stem cells administrated for intra-articular use10 x 10E6 ASC intra-articular injection (5 ml) |
| Group 3 | Experimental | Biological: Autologous adipose derived stem cells administrated for intra-articular use50 x 10E6 ASC intra-articular injection (5 ml) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any disease or medication affecting the bone or cartilage metabolism, including corticoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous adipose derived stem cells administrated for intra-articular useEach 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. | Biological | Group 2, Group 3 |
| Autologous adipose derived stem cells administrated for intra-articular useEach 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. | Biological | Group 1 |
Primary outcome
Recording of Serious Adverse Events
Time frame: 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.
2 secondary outcomes
Functional status of the knee
Time frame: during 365 days following injection
Evaluation of Quality of life
Time frame: during 365 days following injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Derived from this study: PubMed 27217345Pers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Jorgensen, MD principal investigator
University Hospital, Montpellier
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous adipose derived stem cells administrated for intra-articular use in people with Osteoarthritis, run by University Hospital, Montpellier at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recording of Serious Adverse Events (time frame: during 365 days following injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01585857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.