Summary:
The purpose of this research study is to evaluate Stem Cells for disc regeneration.The study is designed to determine whether Stem Cells is safe and effective in treating low back pain by reparing damaged spinal discs.
Qualified Participants Must:
• This Study will include up to 220 men and women, who are between 18 and 60 years of age. Participation in this study will last approximately 12.5 months
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Patients must have low back pain and damage to one or two spinal disc, commonly called Degenerative Disc Disease (DDD) that may require medical treatment.
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Must Not Be Pregnant Or Lactating [Women].
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Have not participated in a clinical study within the last month prior to contacting us.
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Be willing to undergo X-Ray and MRI imaging.
Qualified Participants May Receive:
If you choose to participate in this study, you will be randomly assigned to one of three groups. Depending on the group to which you are assigned, your doctor will inject one of the following into the center of the damaged spinal disc that your doctor has determined is causing the pain.
- Group A: Stem Cells
- Group B: Saline Alone ( No cells)
- Group C: Conservative Care and regimen to which you are currently following. ( No Injection)
You will have a 64% chance of being assigned to the Stem Cell group, 18% chance of being assigned to saline only, and 18% chance of being assigned to the conservative care and current regimen. Both you and your doctor will know to which group you have been assigned. You will also receive follow-up and assessment of your back pain for 12.5 months after dosing. If qualified for the study you will receive a potential of the study sponsor).