Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）

• ClinicalTrials.gov Identifier: NCT03031509
• Recruitment Status: Unknown
• First Posted: January 25, 2017
• Last Update Posted: June 5, 2017
• Sponsor: Shanghai East Hospital
• Collaborator: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
• Information provided by (Responsible Party): Shanghai East Hospital

Tracking Information

• First Submitted Date: January 23, 2017
• First Posted Date: January 25, 2017
• Last Update Posted Date: June 5, 2017
• Estimated Study Start Date: December 2017
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2017)

time for bone union [ Time Frame: 6 months ]

Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 23, 2017)

• pain in fracture site [ Time Frame: 1 year ]
• limb functional score [ Time Frame: 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
• Official Title: Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
• Brief Summary: The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.

Detailed Description

In this study, patients of nonunion after limb fracture will be treated with human amniotic epithelial cells. Clinical and radiological assessment is performed.

hAECs developing from the epiblast as early as 8 days after fertilization, recent data reported indicate that hAECs possess proper osteogenic differentiation potential and a localized modulatory influence on the early tissue remodeling process, making these cells a promising stem cell source for bone regeneration after fractures.

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Nonunion Fracture

Intervention

• Biological: Human Amniotic Epithelial Cells
  Human Amniotic Epithelial Cells transplant after debridement
• Procedure: debridement
  debridement

Study Arms

• Experimental: hAECs treatment
  Human Amniotic Epithelial Cells of 50 million transplant to nonunion site after debridement surgery
  Interventions:

  • Biological: Human Amniotic Epithelial Cells
  • Procedure: debridement
• Sham Comparator: debridement surgery
  debridement surgery
  Intervention: Procedure: debridement

Publications *

• Miki T, Lehmann T, Cai H, Stolz DB, Strom SC. Stem cell characteristics of amniotic epithelial cells. Stem Cells. 2005 Nov-Dec;23(10):1549-59. Epub 2005 Aug 4.
• Si J, Dai J, Zhang J, Liu S, Gu J, Shi J, Shen SG, Guo L. Comparative investigation of human amniotic epithelial cells and mesenchymal stem cells for application in bone tissue engineering. Stem Cells Int. 2015;2015:565732. doi: 10.1155/2015/565732. Epub 2015 Mar 5.
• Jiawen S, Jianjun Z, Jiewen D, Dedong Y, Hongbo Y, Jun S, Xudong W, Shen SG, Lihe G. Osteogenic differentiation of human amniotic epithelial cells and its application in alveolar defect restoration. Stem Cells Transl Med. 2014 Dec;3(12):1504-13. doi: 10.5966/sctm.2014-0118. Epub 2014 Nov 3.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 23, 2017): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• diagnosed with nonunion of limbs by x-ray and bone scan;
• compliance to treatment and long term follow-up;
• be able and willing to participate in the study;
• written informed consent before study.

Exclusion Criteria:

• pregnant or breastfeeding;
• patients with malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppressant therapy ( chemotherapy or steroids), OR health status, mental diseases, which will influence the study;
• patients undergoing any other treatment that are not related to this study;
• others considered not appropriate selected patients.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03031509
• Other Study ID Numbers: DFSC-2017（CR）-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Shanghai East Hospital
• Study Sponsor: Shanghai East Hospital
• Collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Investigators

• Principal Investigator: XIA LI, Dr.; Shanghai East Hospital

• PRS Account: Shanghai East Hospital
• Verification Date: June 2017