Responsible, Safe, and Effective Use of
Biologics in the Management of Low Back
Pain: American Society of Interventional Pain
Physicians (ASIPP) Guidelines
Authors: Manchikanti Laxmaiah 
Published: February 2021

Background: Regenerative medicine is a medical subspecialty that seeks to recruit and enhance
the body’s own inherent healing armamentarium in the treatment of patient pathology. This
therapy’s intention is to assist in the repair, and to potentially replace or restore damaged tissue
through the use of autologous or allogenic biologics. This field is rising like a Phoenix from the
ashes of underperforming conventional therapy midst the hopes and high expectations of patients
and medical personnel alike. But, because this is a relatively new area of medicine that has yet to
substantiate its outcomes, care must be taken in its public presentation and promises as well as
in its use.
Objective: To provide guidance for the responsible, safe, and effective use of biologic therapy in
the lumbar spine. To present a template on which to build standardized therapies using biologics.
To ground potential administrators of biologics in the knowledge of the current outcome statistics
and to stimulate those interested in providing biologic therapy to participate in high quality
research that will ultimately promote and further advance this area of medicine.
Methods: The methodology used has included the development of objectives and key questions.
A panel of experts from various medical specialties and subspecialties as well as differing regions
collaborated in the formation of these guidelines and submitted (if any) their appropriate disclosures
of conflicts of interest. Trustworthy standards were employed in the creation of these guidelines.
The literature pertaining to regenerative medicine, its effectiveness, and adverse consequences
was thoroughly reviewed using a best evidence synthesis of the available literature. The grading
for recommendation was provided as described by the Agency for Healthcare Research and Quality
(AHRQ).
Summary of Evidence:
Lumbar Disc Injections:
Based on the available evidence regarding the use of platelet-rich plasma (PRP), including one
high-quality randomized controlled trial (RCT), multiple moderate-quality observational studies, a
single-arm meta-analysis and evidence from a systematic review, the qualitative evidence has been
assessed as Level III (on a scale of Level I through V) using a qualitative modified approach to the
grading of evidence based on best-evidence synthesis.
Based on the available evidence regarding the use of medicinal signaling/ mesenchymal stem cell
(MSCs) with a high-quality RCT, multiple moderate-quality observational studies, a single-arm
meta-analysis, and 2 systematic reviews, the qualitative evidence has been assessed as Level III (on
a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis.
Lumbar Epidural Injections
Based on one high-quality RCT, multiple relevant moderate-quality observational studies and a single-arm meta-analysis, the
qualitative evidence has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the
grading of evidence based on best evidence synthesis.
Lumbar Facet Joint Injections
Based on one high-quality RCT and 2 moderate-quality observational studies, the qualitative evidence for facet joint injections with
PRP has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence
based on best evidence synthesis.
Sacroiliac Joint Injection
Based on one high-quality RCT, one moderate-quality observational study, and one low-quality case report, the qualitative evidence
has been assessed as Level IV (on a scale of Level I through V) using a qualitative modified approach to the grading of evidence
based on best evidence synthesis.
Conclusion: Based on the evidence synthesis summarized above, there is Level III evidence for intradiscal injections of PRP and
MSCs, whereas the evidence is considered Level IV for lumbar facet joint, lumbar epidural, and sacroiliac joint injections of PRP, (on
a scale of Level I through V) using a qualitative modified approach to the grading of evidence based on best evidence synthesis.
Regenerative therapy should be provided to patients following diagnostic evidence of a need for biologic therapy, following a
thorough discussion of the patient’s needs and expectations, after properly educating the patient on the use and administration of
biologics and in full light of the patient’s medical history. Regenerative therapy may be provided independently or in conjunction
with other modalities of treatment including a structured exercise program, physical therapy, behavioral therapy, and along with the
appropriate conventional medical therapy as necessary. Appropriate precautions should be taken into consideration and followed
prior to performing biologic therapy. Multiple guidelines from the Food and Drug Administration (FDA), potential limitations in
the use of biologic therapy and the appropriate requirements for compliance with the FDA have been detailed in these guidelines.
Key words: Regenerative medicine, platelet-rich plasma, medicinal signaling cells, mesenchymal stem cells, stromal vascular
fraction, bone marrow concentrate, chronic low back pain, discogenic pain, facet joint pain, Food and Drug Administration,
minimal manipulation, evidence synthesis