Evaluation of intra-venous mesenchymal stem cells for the treatment of small joint osteoarthritis

Not Applicable

• Conditions: Osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12619000883112
• Lead Sponsor: Melbourne Stem Cell Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-21
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1.Provision of written informed consent
2.Males and females aged 18 years or over
3.Documented radiological diagnosis of small joint osteoarthritis of the hand (> 2 joints).
4.Primary OA treatment already undertaken, defined as one or more of:
a)analgesia/anti-inflammatory medication, supplements approved by the treating clinician (e.g. glucosamine sulphate),
5.Female subjects of child bearing potential must be willing to comply with the contraceptive requirements of the study. Hormonal contraception by itself will be considered inadequate. All women of child bearing potential must return a negative serum pregnancy test result at Screening and a negative urine pregnancy test before injection of IP. Note, proof of postmenopausal status will be confirmed with the presence of amenorrhea for more than 12 months and a follicle stimulating hormone level of greater than 25 IU/L.
6.Male subjects (and their female partners) must be willing to comply with the contraceptive requirements of the study.
7.Sufficient English skills to communicate well with the PI and site personnel and agree to comply with all the study procedures and requirements.

Exclusion Criteria

1.Clinically significant abnormalities in the screening physical examination, vital signs, ECG, or clinical laboratory tests, as determined by the PI. Repeat testing may be performed at the PI’s discretion.
2.History of an atypical pain syndrome.
3.History of infective or inflammatory joint disorders, or suspected infective or inflammatory joint disease
4.History of other musculoskeletal or neurological condition that effects upper limb function.
5.History of significant drug allergies (including penicillin and streptomycin and to any excipients) including a history of anaphylactic reaction (particularly reactions to anesthetic agents).
6.Known allergy or intolerance to bovine meats, products containing bovine serum albumin and/or products derived from bovine sources.
7.Intake of prescribed anticoagulants including warfarin within 21 days prior to Day -1. Low dose (up to 100 mg daily) acetylsalicylic acid is permitted.
8.Female subjects who are pregnant or lactating.
9.Females who are planning a pregnancy at any time during the following 12 months.
10.Major surgery anticipated at any time during the following 12 months.
11.Any contraindication to an X-ray or MRI of the study hand.
12.Unlikely to comply with the clinical study protocol; e.g. uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study.
13.Any other condition, which in the opinion of the PI precludes the subject’s participation in the clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of autologous adipose-derived mesenchymal stem cells (AdMSC) administered intravenously for the treatment of small joint osteoarthritis.<br> - safety will be assessed using routine medical vital sign observations, ECG assessment, and blood biochemistry laboratory testing. These tests will be conducted at baseline, time of stem cell administration and throughout the follow-up period of 12 months. <br>- Adverse Events will be assessed by the principle investigator and clinical investigator and also by a Data and Safety Management Committee at regular intervals. Adverse events will be collected from medical records and participant self reporting of symptoms.<br>- No serious adverse events have been reported in previous studies.[Assessment at baseline, day 7 and months 1,3,6,9 and 12 post commencement of therapy. Formal primary end point will be at 12 months.]

Secondary Outcome Measures

Name	Time	Method
Pain using the validated questionnaire Numeric Pain Rating Scale[Outcome scores assessed at 0, 1, 3, 6, 9 and 12months];Function assessed using the validated questionnaire Disability of arm, shoulder and hand (DASH) score.[Outcome scores completed at 0,1,3,6,9 and 12 months];Structural outcome assessed using MRI including synovitis, sunchondral oedema, osteophyte formation and cartilage loss/[MRI performed at baseline and 12months];Function assessed using the Short Form Health Survey 36[Outcome scores completed at 0,1,3,6,9 and 12 months]