None listed
Conditions
Brief summary
This is a proof of concept pilot study to evaluate the safety and tolerability of autologous adipose-derived mesenchymal stem cells (ADMSC) administered intravenously for the treatment of small joint osteoarthritis. A secondary objective will be to assess efficacy with pain and functional assessment over a 12month follow-up period.
Interventions
This study will look to prospectively assess the response of small joint osteoarthritis to intravenous mesenchymal stem cell therapy using the following protocol :
- a single intra-venous infusion of mesenchymal stem cells (1.5million per kg of body weight) at commencement of treatment (baseline). Mesenchymal stem cells will be mixed with a plasmalyte-148 solution to a total of up to 50mls and will be infused over a 20minute period.
- participants will be routinely monitored on the day of infusi
This study will look to prospectively assess the response of small joint osteoarthritis to intravenous mesenchymal stem cell therapy using the following protocol : - a single intra-venous infusion of mesenchymal stem cells (1.5million per kg of body weight) at commencement of treatment (baseline). Mesenchymal stem cells will be mixed with a plasmalyte-148 solution to a total of up to 50mls and will be infused over a 20minute period. - participants will be routinely monitored on the day of infusion for a period of 3hours. - prior to administration participants wil undergo a routine 12-lead ECG, and have blood samples taken for clinical laboratory testing. This will be a single treatment group uncontrolled case series pilot study. Autologous adipose derived mesenchymal stem cells will be used due to the ease of harvest (liposuction) and safety. The 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 suitable 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-venous infusion will be performed under the supervision of a qualified medical clinician with a medical degree equivalent of Bachelor of Medicine & Bachelor of Surgery (MBBS). 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.
Sponsors
Melbourne Stem Cell Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
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.
Outcome results
None listed