CTRI/2015/04/005662CompletedPhase 3
A prospective, open-label, multicentric study to assess the safety and efficacy of Autologous Adult Live Cultured Osteoblasts (OSSRONâ?¢) in subjects with Avascular Necrosis (AVN). - NA
Regenerative Medical Services Pvt Ltd0 sites12 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 12
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Male or female subjects aged 18 to 65 years (both inclusive) with stage I to stage IIB on ficat artlet grading scale with less than 2mm collapse for avascular necrosis of hip joint(s) either unilateral or bilateral.
- •2. Subjects with avascular necrosis of hip joint(s) diagnosed by clinical symptoms and radiological evaluation by digital X-Ray and MRI (Not less than 1.5 T MRI).
- •3. Subject is willing and able to comply with post-operative weight-bearing restrictions and rehabilitation.
- •4.Body mass index (BMI) <35 kg/m2.
- •5. Subjects (or legally acceptable representative [LAR] of impartial witness) who are able to provide written informed consent prior to participation in the study.
Exclusion Criteria
- •1. Subjects who have stage III on ficat artlet grading scale with more than 2mm and/or completely collapsed femoral head.
- •2.Subjects who have induced AVN due to alcohol.
- •3.Subjects who have undergone recurrent injuries to hip.
- •4.Subjects who have previously undergone core decompression or multiple drilling in affected area.
- •5.Subjects who have previously undergone autogenous/allograft, partial or total bone grafting procedure in affected area.
- •6.Subjects who have previously undergone hip joint arthroplasty (partial / complete) of affected area.
- •7.Subjects who have previously undergone any organ transplant or bone marrow transplantation.
- •8.Subjects with malignant tumors, who have undergone radiotherapy or chemotherapy within last 2 years.
- •9.Subjects who have history of hematological malignancies.
- •10.Subjects who have hemoglobinopathies such as and not limited to sickle cell anemia, leukemia and thalassemia.
- •11.Subjects who have ongoing history of cardiac, renal and hepatic dysfunctions.
- •12.Subjects with inflammatory arthritis, such as osteoarthritis and gouty arthritis.
- •13.Subjects diagnosed with osteoporosis.
- •14.Subjects on medication such as bisphosphonate, osteoporosis drugs.
- •15.Subjects with ongoing treatment of continued steroids or drug abuse/dependency.
- •16.Subjects who are pregnant, breast-feeding or have a positive pregnancy test prior to receiving the therapy.
- •17.Subjects with type 1 or type 2 Diabetes Mellitus having pre-prandial blood glucose levels >130mg/dL and post prandial blood glucose levels >180 mg/dL at screening visit.
- •18.Subjects with acute infections of bone, currently on treatment with antibiotics and antimicrobials will not be included. Such subjects may be considered after completion of adequate treatment and as per Investigatorâ??s discretion.
- •19.Subjects with psychiatric disorders who are considered inappropriate to participate in this study by the principal investigator. Subjects with psychiatric disorders who are on stable medication may be included in the study as per investigatorâ??s discretion.
- •20.History of receiving an investigational product within 30 days prior to enrollment in this study.
- •21.Subjects who are tested positive for HIV, Hepatitis B or Hepatitis C and Syphilis.
- •22.Subjects who are diagnosed with tuberculosis at the time of screening.
Investigators
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