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Updated: Mar 1, 2026
Isolation, Cryopreservation and Culture of Human Amnion Epithelial Cells for Clinical Applications
Published on: December 21, 2014
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.
Study Design:
Prospective, randomized controlled trial.
Objective:
To compare pain, physical/mental functional recovery and recurrent herniation for patients following lumbar microdiscectomy with and without the use of a cryopreserved amniotic tissue graft.
Summary Of Background Data:
Although microdiscectomy procedures are routinely successful for patients with lumbar radiculopathy due to herniated disc disease, residual low back pain, and recurrent herniation remain unsolved clinical problems.
Methods:
Following Investigated Review Board approval, 80 subjects were randomized in a 1:1 ratio to either receive cryopreserved amniotic (cAM) tissue or no tissue following elective lumbar microdiscectomy surgery. cAM grafts were applied to the annular defect at the conclusion of the procedure. Patients provided preoperative and postoperative clinical assessment data out to 24 months using the Oswestry Disability Index (ODI), Short Form-12 (SF-12) Health Survey, and Visual Analog Pain Scale for back and leg pain. Patients with symptomatic recurrent disc herniation were recorded.
Results:
In total, 48 males and 32 females with an average age of 47.2 years were included. Mean ODI scores for subjects treated with cAM graft demonstrated statistically greater improvement at 6 weeks (14.49 vs. 21.82; P=0.05) and 24 months (6.62 vs. 14.40; P=0.02) compared with controls. Similarly, SF-12 Physical Component Scores demonstrated statistically greater gains in the cAM group at both the 6 weeks and 24 months. None of the subjects in the cAM graft group sustained a recurrent herniation at the same surgical level, whereas 3 patients in the control group sustained a recurrent herniation at the same surgical level, with 2 requiring fusion to manage persistent pain.
Conclusions:
The data demonstrate statistically superior clinical outcomes following lumbar microdiscectomy as measured by ODI and SF-12 (physical composite scale) and a lower rate of recurrent herniation with the use of a cAM tissue graft compared with traditional microdiscectomy.
Insights
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.
