ACTRN12619000883112尚未招募未知
The evaluation of safety of intra-venous autologous adipose derived mesenchymal stem cell therapy in the treatment of small joint osteoarthritis. A pilot study.
Melbourne Stem Cell Centre0 个研究点目标入组 10 人开始时间: 2019年6月21日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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