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Isolation, Cryopreservation and Culture of Human Amnion Epithelial Cells for Clinical Applications
Published on: December 21, 2014
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Cryopreserved Amniotic Membrane Improves Clinical Outcomes Following Microdiscectomy
D Greg Anderson1, Victor Popov, Andrew L Raines
1*Department of Orthopaedic Surgery and Neurological Surgery, Thomas Jefferson University †Rothman Institute, Philadelphia, PA ‡Amniox Medical Inc., Atlanta, GA.
Clinical Spine Surgery
|May 31, 2017
Summary
Cryopreserved amniotic (cAM) tissue grafts significantly improved recovery after lumbar microdiscectomy, reducing pain and recurrent herniation. Patients receiving cAM grafts showed better functional recovery and fewer reherniations compared to controls.
Area of Science:
- Neurosurgery
- Regenerative Medicine
- Orthopedics
Background:
- Lumbar microdiscectomy is common for radiculopathy but often results in residual pain and recurrent herniation.
- Unmet clinical needs persist for improving outcomes after lumbar microdiscectomy.
Purpose of the Study:
- To compare outcomes of lumbar microdiscectomy with and without cryopreserved amniotic (cAM) tissue grafts.
- To evaluate the impact of cAM grafts on pain, functional recovery, and recurrent herniation rates.
Main Methods:
- Prospective, randomized controlled trial involving 80 patients undergoing lumbar microdiscectomy.
- Patients were randomized to receive either a cAM tissue graft or no graft applied to the annular defect.
- Outcomes were assessed using Oswestry Disability Index (ODI), SF-12 Health Survey, and Visual Analog Pain Scale up to 24 months.
Main Results:
- The cAM graft group showed statistically significant improvements in ODI scores at 6 weeks and 24 months compared to controls.
- SF-12 Physical Component Scores were also significantly higher in the cAM group at both time points.
- No recurrent herniations occurred in the cAM group, versus 3 in the control group (2 requiring fusion).
Conclusions:
- Cryopreserved amniotic tissue grafts enhance clinical outcomes after lumbar microdiscectomy.
- cAM grafts lead to superior functional recovery and a reduced rate of recurrent herniation.
- The use of cAM tissue represents a promising adjunct to traditional lumbar microdiscectomy.
