ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000638336

Ethics application status

Approved

Date submitted

22/03/2017

Date registered

2/05/2017

Date last updated

4/06/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

The evaluation of mesenchymal stem cells in the treatment of arthritis

Scientific title

Evaluation of adipose derived mesenchymal stem cells for the treatment of arthritis

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Arthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Inflammatory and Immune System

Rheumatoid arthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will look to prospectively assess the response of symptomatic joint arthritis to mesenchymal stem cell therapy using the following protocol :
- Intra-articular injection of up to 50million stem cells at 0 and 6 months.

This will be a single treatment group uncontrolled case series.

Autologous adipose derived mesenchymal stem cells will be used due to the ease of harvest (liposuction) and safety. A small abdominal liposuction will be performed by an appropriately qualified medical clinician. This will be a day procedure and will take up to 1 hour. Isolation and expansion of mesenchymal stem cells will be performed in a suitably certified clean room facility operated by Magellan Stem Cells.

Commencement of therapy will be performed no earlier than 8 weeks after liposuction due to time taken to isolate and expand the mesenchymal stem cells.

Intra-articular (joint) injections will be performed by a suitably qualified procedural clinician with an medical degree equivalent of Bachelor of Medicine & Bachelor of Surgery (MBBS). These injections will be performed under radiological guidance.

Dose of mesenchymal stem cells will be dependent on the size of joint treated (ie. Knee - 50Millions MSCs, hip/ankle/shoulder - 20Millions MSCs, small joints of the hand - 10Million MSCs)

Only one joint/region will be treated at any given time.

The repeat injection at 6months will use mesenchymal stem cells previously isolated, expanded and stored from the initial harvest procedure. Mesenchymal stem cell will be cryopreserved in clinical grade qualified MSC cryoprotectant media using a validated control rate freezing method and stored in liquid nitrogen until use.

Intervention code [1]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Joint Pain : assessed using the Numeric Pain Rating Scale

Timepoint [1]

Assessment at 0,1,3,6,9 and 12monts post commencement of therapy

Primary outcome [2]

Pain and functional outcome : using a validated joint specific outcome score (i.e Knee injury and Osteoarthritis Outcome Score - KOOS, Hip injury and Osteoarthritis Outcome Score - HOOS)

Timepoint [2]

Assessment at 0,1,3,6,9 and 12months post commencement of therapy

Secondary outcome [1]

MRI assessment of cartilage volume.

Timepoint [1]

Assessed at commencement of study and again at 12months

Secondary outcome [2]

MRI assessment of cartilage quality using T2mapping techniques

Timepoint [2]

Assessed at commencement study and again at 12months

Eligibility

Key inclusion criteria

Inclusion Criteria :
1. Radiological diagnosis of arthritis using the American College of Rheumatology criteria (Altman, 1986).
2. Primary arthritis treatment already undertaken defined as: analgesia/anti-inflammatory medication, supplements approved by the treating clinician (eg glucosamine sulphate), an attempted exercise program prescribed by a physiotherapist or medical practitioner for at least 8 weeks (Petrella, 2000), weight loss and nutritional management as prescribed by a dietician or medical practitioner for at least 8 weeks, and biomechanical management including bracing if appropriate as prescribed by a physiotherapist, podiatrist or medical practitioner. Autologous MSC is an invasive treatment and guidelines recommend trialling conservative measures as the first line of treatment in osteoarthritis (Thompson, Gordon et al. 2009).
3. Sufficient English skills to complete the questionnaires required for the study, as well as to understand the instructions given by the study doctors. This is required as no funding is available for translation or interpreters, and the outcome questionnaires to be used have only been validated in English language.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria:
1. Age <18yrs.
2. Pregnancy (accepted contra-indication as no safety data on this population).
3. Breastfeeding (accepted contra-indication as no safety data on this population).
4. Have other causes of their symptoms suspected to be due to serious pathology such as tumour or referral from the spine. These conditions are not under investigation within the current project.
5. Current cancer.
6. History of significant organ impairment/failure (ie. renal failure).
7. History of allergy to any substances used within the treatments.
8. Bovine allergy

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data analysis will focus on change in pain, function and quantitative MRI measures (with 95% confidence intervals) at each of the follow-up points (1-month, 3-months, 6-months and 12-months). Analyses will be conducted using SPSS Version 21, with alpha set at 0.05 using a two-tailed hypothesis. Continuous data will be analysed using linear mixed models. These were chosen for their strength in analysing longitudinal biological data and accounting for correlations associated with repeated measurement. The mixed models will adjust for the baseline score of the outcome of interest as recommended by the revised CONSORT statement. Ordinal data will be analysed using the Mann Whitney U test.
At each follow-up point, participants will be dichotomised according to whether they achieved the minimum clinically important difference of the outcome or not, and then the risk ratio, risk difference and number needed to treat will be calculated along with 95% confidence intervals. Statistical significance will be evaluated using Chi square analysis.
All participants who withdraw from treatment for any reason will continue to be contacted for follow-up assessments and informed that their data are still required. Missing data will be handled via restricted maximum likelihood estimation within the linear mixed models. Given the popularity of simple data imputation methods we will undertake a secondary sensitivity analysis to determine whether the results would differ if missing data were replaced using the last observation carried forward method.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

15/05/2017

Actual

15/05/2017

Date of last participant enrolment

Anticipated

1/01/2019

Actual

Date of last data collection

Anticipated

1/01/2020

Actual

Sample size

Target

200

Accrual to date

100

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Participants in the study fund their own treatment.

Address [1]

Country [1]

Primary sponsor type

Commercial sector/Industry

Name

Melbourne Stem Cell Centre

Address

Level 2, 116-118 Thames St
Box Hill Nth 3128
Victoria

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Magellan Stem Cells

Address [1]

Level 2, 116-118 Thames St
Box Hill Nth 3128
Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Charles Sturt University Human Research Ethics Committee

Ethics committee address [1]

The Executive Officer
Human Research Ethics Committee
Charles Sturt University
Locked Bag 588
Wagga Wagga NSW 2678

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2016

Approval date [1]

07/12/2016

Ethics approval number [1]

H16171

Summary

Brief summary

The purpose of this study is to formally follow up and record the effectiveness of autologous (your own) stem cell injections in the treatment of arthritis.  A secondary objective is to determine whether stem cell therapy offers disease modifying potential and therefore whether it can limit, prevent or possibly reverse progression of arthritis.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr James Wickham

Address

School of Biomedical Sciences
Charles Sturt University
Leeds Parade
Orange, NSW 2800

Country

Australia

Phone

+61 3 92708000

Fax

[email protected]

Contact person for public queries

Name

James Wickham

Address

School of Biomedical Sciences
Charles Sturt University
Leeds Parade
Orange, NSW 2800

Country

Australia

Phone

+61 3 92708000

Fax

[email protected]

Contact person for scientific queries

Name

Julien Freitag

Address

Melbourne Stem Cell Centre
116-118 Thames St
Box Hill North
Vic 3128

Country

Australia

Phone

+61 3 92708000

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
23507	Informed consent form					372613-(Uploaded-01-03-2024-15-24-22)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Effect of autologous adipose-derived mesenchymal stem cell therapy in the treatment of acromioclavicular joint osteoarthritis	2019	https://doi.org/10.1136/bcr-2018-227865
Embase	Differentiation Potential of Early- A nd Late-Passage Adipose-Derived Mesenchymal Stem Cells Cultured under Hypoxia and Normoxia.	2020	https://dx.doi.org/10.1155/2020/8898221
Embase	Effect of autologous adipose-derived mesenchymal stem cell therapy in combination with autologous platelet-rich plasma in the treatment of elbow tendinopathy.	2020	https://dx.doi.org/10.1136/bcr-2020-234592
Embase	Effect of autologous adipose-derived mesenchymal stem cell therapy in the treatment of an osteochondral lesion of the ankle.	2020	https://dx.doi.org/10.1136/bcr-2020-234595
Embase	Evaluation of autologous adipose-derived mesenchymal stem cell therapy in focal chondral defects of the knee: A pilot case series.	2020	https://dx.doi.org/10.2217/rme-2020-0027
Embase	Real-world evidence of mesenchymal stem cell therapy in knee osteoarthritis: a large prospective two-year case series.	2022	https://dx.doi.org/10.2217/rme-2022-0002

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically