NCT00813813

Phase I/II, Multicenter, Open-label, Single Administration, Dose Finding, Clinical Trial to Evaluate the Safety and Tolerability of Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

Completed Phase 1/Phase 2 Results posted Last updated 26 January 2016

What this trial tests

Phase 1/Phase 2 trial testing Intradiscal rhGDF-5 in Degenerative Disc Disease in 32 participants. Completed in 1 June 2013.

Timeline

1 June 2008

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	DePuy Spine
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 June 2008
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	8 locations across United States

Drugs / interventions tested

• Intradiscal rhGDF-5 — full drug profile →

Conditions studied

• Degenerative Disc Disease — all drugs for Degenerative Disc Disease →

Sponsor

DePuy Spine — full company profile →

Who can join

18 and older, any sex, with Degenerative Disc Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Neurological Assessment for Motor Function and Reflexes/Sensory
  Time frame: 12 months
  Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against
• Treatment Emergent Adverse Events- Relationship to Study Drug
  Time frame: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
  Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.

Sponsor's own description

Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intervertebral Disc Degeneration: Biomaterials and Tissue Engineering Strategies toward Precision Medicine.
   Mohd Isa IL, Mokhtar SA, Abbah SA, Fauzi MB, et al · · 2022 · cited 101× · PMID 35373924 · DOI 10.1002/adhm.202102530
2. Intervertebral disc degeneration-Current therapeutic options and challenges.
   Samanta A, Lufkin T, Kraus P. · · 2023 · cited 98× · PMID 37483952 · DOI 10.3389/fpubh.2023.1156749
3. Intervertebral Disc Nucleus Repair: Hype or Hope?
   Tendulkar G, Chen T, Ehnert S, Kaps HP, et al · · 2019 · cited 54× · PMID 31344903 · DOI 10.3390/ijms20153622
4. Potential regenerative treatment strategies for intervertebral disc degeneration in dogs.
   Bach FC, Willems N, Penning LC, Ito K, et al · · 2014 · cited 46× · PMID 24387033 · DOI 10.1186/1746-6148-10-3
5. Leaping the hurdles in developing regenerative treatments for the intervertebral disc from preclinical to clinical.
   Thorpe AA, Bach FC, Tryfonidou MA, Le Maitre CL, et al · · 2018 · cited 43× · PMID 31463447 · DOI 10.1002/jsp2.1027
6. Recent Advances in Managing Spinal Intervertebral Discs Degeneration.
   Costăchescu B, Niculescu AG, Teleanu RI, Iliescu BF, et al · · 2022 · cited 38× · PMID 35742903 · DOI 10.3390/ijms23126460
7. A new perspective on intervertebral disc calcification-from bench to bedside.
   Novais EJ, Narayanan R, Canseco JA, van de Wetering K, et al · · 2024 · cited 30× · PMID 38253615 · DOI 10.1038/s41413-023-00307-3
8. Bioactive peptides and proteins for tissue repair: microenvironment modulation, rational delivery, and clinical potential.
   Hao ZW, Zhang ZY, Wang ZP, Wang Y, et al · · 2024 · cited 24× · PMID 39639374 · DOI 10.1186/s40779-024-00576-x