Evidence map›Paper›PMID 38925869›Full record

ArticleInternational journal of spine surgery2024

Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration-Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial.

Matthew F Gornet, Douglas P Beall, Timothy T Davis, Domagoj Coric, Michael LaBagnara, Angela Krull, Michael J DePalma, Patrick C Hsieh, Srinivas Mallempati, Francine W Schranck and 2 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of spine surgery, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03347708 (A Prospective, Randomized, Double-Blinded, Vehicle- and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single-Level, Symptomatic Lumbar Intervertebral Disc Degeneration), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03347708 phase1completednot on this map

A Prospective, Randomized, Double-Blinded, Vehicle- and Placebo-Controlled, Multicenter Study to Evaluate the Safety and Preliminary Efficacy of IDCT in Subjects With Single-Level, Symptomatic Lumbar Intervertebral Disc Degeneration

TypeinterventionalSponsorDiscGenics, Inc.Ran2018 to 2022Enrolled60ConditionsDegenerative Disc DiseaseArmsIDCT, Saline Solution, Sodium Hyaluronate
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  6. Intervertebral disc degeneration.Nature reviews. Disease primers · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Matthew F GornetThe Orthopedic Center of St. Louis, St. Louis, MO, USA.
Douglas P BeallClinical Radiology of Oklahoma, Edmond, OK, USA.
Timothy T DavisSource Health Care, Santa Monica, CA, USA.
Domagoj CoricCarolinas Medical Center/Carolina Neurosurgery & Spine Associates, Charlotte, NC, USA.
Michael LaBagnaraSemmes-Murphey Clinic and Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, TN, USA.
Angela KrullSMART Clinic, Draper, UT, USA.
Michael J DePalmaVirginia iSpine Physicians/Virginia Spine Research Institute, Richmond, VA, USA.
Patrick C HsiehLos Angeles-USC Health Care Center, Los Angeles, CA, USA.
Srinivas MallempatiAlabama Clinical Therapeutics, Birmingham, AL, USA.
Francine W SchranckSPIRITT Research, St. Louis, MO, USA.
Colleen KellyKelly Statistical Consulting, Carlsbad, CA, USA.
Kevin T FoleySemmes-Murphey Clinic and Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, TN, USA kfoley@semmes-murphey.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgenitor cells derived from intervertebral disc tissue demonstrated immunomodulatory and regenerative properties in preclinical studies. We report the safety and efficacy results of a US Food and Drug Administration-approved clinical trial of these cells for the treatment of symptomatic degenerative disc disease.

methodsSixty patients with symptomatic single-level lumbar degenerative disc disease (mean age 37.9 years, 60% men) were enrolled in a randomized, double-blinded, placebo-controlled Phase I/Phase II study at 13 clinical sites. They were randomized to receive single intradiscal injections of either low-dose cells (

resultsAt week 52, the high-dose group had a mean VAS percentage decrease from baseline (-62.8%,

conclusionsHigh-dose allogeneic disc progenitor cells produced statistically significant, clinically meaningful improvements in back pain and disc volume at 1 year following a single intradiscal injection and were safe and well tolerated. These improvements were maintained at 2 years post-injection. LEVEL OF EVIDENCE: 1: CLINICAL

trial registrationNCT03347708-Study to Evaluate the Safety and Preliminary Efficacy of Injectable Disc Cell Therapy, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration.

Indexed as

degenerative disc diseasedisc progenitor cellslumbar disc injectable treatmentlumbar disc volume

Identifiers

PMID38925869
PMCPMC11535772

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.