Safety and Efficacy of Autologous Bone Marrow Stem Cells for Treating Osteoarthritis
Use of Autologous Bone Marrow Stem Cell Transplantation for Therapeutic Chondrogenesis in Moderate to Severe Osteoarthritis - ABM & LAM ST-OA Study
Osteoarthritis is a leading cause of chronic disability in elderly and the risk of disability attributed to osteoarthritis is as great as or greater than due to any other medical condition in that age group. Several cross sectional studies have demonstrated an age related increase in the prevalence of osteoarthritis of knee(5). Results of survey are similar with most surgeons reporting 50+ years age group being commonest at initial presentation and that the incidence increases with advancing age. Interestingly some surgeons have noticed earlier occurrence of osteoarthritis in 40+ years age group and one has to be careful to screen for secondary causes in this younger age group patients.
While pain relief is the primary treatment goal of osteoarthritis medications, localized inflammation may also be relieved by using certain drugs. Managing osteoarthritis pain can involve medications, natural remedies, exercise, weight loss, joint protection, mobility aids, assisted devices and more.
Stem cell therapy, using cells extracted from the same patient or suitable alternative human sources, targets diseases which are either incurable or with no complete or effective treatment available in the traditional healthcare system. Since this therapy is based on the concept of regenerating damaged cells in the injured or disease-affected areas of the body, it is called regenerative medicine
Autologous stem cells provide an attractive option for osteoarthritis patients and their clinicians.
In our present study we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells in treatment of Osteoarthritis for therapeutic chondrogenesis through delivery of stem cells into the knee joint space in ten Indian patients.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Karnataka
-
Bengaluru、Karnataka、インド、560010
- St. Theresa's Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Must be able to give voluntary written (patients may not be able to write) consent.
- Must be able to understand study information provided to him.
- Age 30 to 70, inclusive
- OA Kellgren and Lawrence classification 3 & 4
- No ligamentous laxity i.e. stable
- Ability to understand and willingness to sign consent form
- The participant is able to comply with and understand the required visit schedule and all required tests and procedures.
Exclusion Criteria:
- Serious pre-existing medical conditions like Diabetes Mellitus, Chronic Renal Failure, Rheumatoid Arthritis, Collagen vascular diseases and Autoimmune diseases
- Pregnant or lactating woman
- Inflammatory arthritis
- Oral steroid, methotrexate (immune suppressants)
- History of drug or alcohol abuse or chronic smoking
- Poor patient compliance
- Infectious disease test positive for HIV 1&2, HbsAg, HCV and VDRL.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:自家骨髄幹細胞
|
Stem cells isolated from the patient's own bone marrow.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score
時間枠:Baseline, 3 months, 6 months, 1 year
|
Baseline, 3 months, 6 months, 1 year
|
|
安全性と忍容性の尺度としての有害事象のある参加者の数
時間枠:1年
|
1年
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Changes in the MRI knee with cartilage mapping and clinical improvement
時間枠:Baseline, 6 months, 1 year
|
Baseline, 6 months, 1 year
|
協力者と研究者
捜査官
- 主任研究者:Rudraprasad, M.S、St. Theresa's Hospital
- スタディディレクター:Alphy Zachson, M.B.B.S、International Stemcell Services Limited
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。